Category Archives: North Carolina Stem Cells

MELVILLE, NY., June 22, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company or BioRestorative) ( BRTX), a clinical stage company focused on stem cell-based therapies, today announced it has reached an agreement with its second clinical site for its Phase 2 clinical trial targeting chronic lumbar disc disease (cLDD). The Center for Clinical Research, which is located in North Carolina, is BioRestoratives second clinical trial contract executed.

BioRestoratives Phase 2 trial is a double-blind controlled, randomized study to evaluate the safety and preliminary efficacy of a single dose intradiscal injection of the Companys autologous investigational stem cell-based therapeutic, BRTX-100. A total of up to 99 eligible patients will be randomized at up to 15 sites in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion.

With the signing of our second clinical trial agreement, we are pleased to welcome Dr. Richard Rauck who will be the principal investigator for The Center for Clinical Research, said Lance Alstodt, Chief Executive Officer of BioRestorative Therapies. Dr. Rauck has extensive clinical experience and brings expertise in the field of cell-based regenerative medicine, which is invaluable for a successful clinical trial.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. Pursuant to authorization received from the Food and Drug Administration, we have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission and other public filings. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email: [emailprotected]

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BioRestorative Therapies Annou - GuruFocus.com

Shrooms, Alice, tweezes, mushies, hongos, pizza toppings, magic mushrooms -- everyday lingo for psychedelic mushrooms seems to grow with each generation. Yet leading mycologist Paul Stamets believes it's time for fans of psilocybin mushrooms to leave such childish slang behind."Let's be adults about this. These are no longer 'shrooms.' These are no longer party drugs for young people," Stamets told CNN. "Psilocybin mushrooms are non-addictive, life-changing substances."Small clinical trials that have shown that one or two doses of psylocibin, given in a therapeutic setting, can make dramatic and long-lasting changes in people suffering from treatment-resistant major depressive disorder, which typically does not respond to traditional antidepressants.Based on this research, the U.S. Food and Drug Administration has described psilocybin as a breakthrough medicine, "which is phenomenal," Stamets said.Psilocybin, which the intestines convert into psilocin, a chemical with psychoactive properties, is also showing promise in combating cluster headaches, anxiety, anorexia, obsessive-compulsive disorder and various forms of substance abuse."The data are strong from depression to PTSD to cluster headaches, which is one of the most painful conditions I'm aware of," said neurologist Richard Isaacson, director of the Alzheimer's Prevention Clinic in the Center for Brain Health at Florida Atlantic University."I'm excited about the future of psychedelics because of the relatively good safety profile and because these agents can now be studied in rigorous double-blinded clinical trials," Isaacson said. "Then we can move from anecdotal reports of 'I tripped on this and felt better' to 'Try this and you will be statistically, significantly better.'"Your brain on mushroomsClassic psychedelics such as psilocybin and LSD enter the brain via the same receptors as serotonin, the body's "feel good" hormone. Serotonin helps control body functions such as sleep, sexual desire and psychological states such as satisfaction, happiness and optimism.People with depression or anxiety often have low levels of serotonin, as do people with post-traumatic stress disorder, cluster headaches, anorexia, smoking addiction and substance abuse. Treatment typically involves selective serotonin reuptake inhibitors, or SSRIs, which boost levels of serotonin available to brain cells. Yet it can take weeks for improvement to occur, experts say, if the drugs even work at all.With psychedelics such as psilocybin and LSD, however, scientists can see changes in brain neuron connectivity in the lab "within 30 minutes," said pharmacologist Brian Roth, a professor of psychiatry and pharmacology at the University of North Carolina at Chapel Hill."One of the most interesting things we've learned about the classic psychedelics is that they have a dramatic effect on the way brain systems synchronize, or move and groove together," said Matthew Johnson, a professor in psychedelics and consciousness at Johns Hopkins Medicine."When someone's on psilocybin, we see an overall increase in connectivity between areas of the brain that don't normally communicate well," Johnson said. "You also see the opposite of that -- local networks in the brain that normally interact with each other quite a bit suddenly communicate less."It creates a "very, very disorganized brain," ultimately breaking down normal boundaries between the auditory, visual, executive and sense-of-self sections of the mind -- thus creating a state of "altered consciousness," said David Nutt, director of the Neuropsychopharmacology Unit in the Division of Brain Sciences at Imperial College London.And it's that disorganization that is ultimately therapeutic, according to Nutt: "Depressed people are continually self-critical, and they keep ruminating, going over and over the same negative, anxious or fearful thoughts."Psychedelics disrupt that, which is why people can suddenly see a way out of their depression during the trip," he added. "Critical thoughts are easier to control, and thinking is more flexible. That's why the drug is an effective treatment for depression."The growth of brain cellsThere's more. Researchers say psychedelic drugs actually help neurons in the brain sprout new dendrites, which look like branches on a tree, to increase communication between cells."These drugs can increase neuronal outgrowth, they can increase this branching of neurons, they can increase synapses. That's called neuroplasticity," Nutt said.That's different from neurogenesis, which is the development of brand new brain cells, typically from stem cells in the body. The growth of dendrites helps build and then solidify new circuits in the brain, allowing us to, for example, lay down more positive pathways as we practice gratitude."Now our current thinking is this neuronal outgrowth probably doesn't contribute to the increased connectivity in the brain, but it almost certainly helps people who have insights into their depression while on psilocybin maintain those insights," Nutt said."You shake up the brain, you see things in a more positive way, and then you lay down those positive circuits with the neuroplasticity," he added. "It's a double whammy."Interestingly, SSRIs also increase neuroplasticity, a fact that science has known for some time. But in a 2022 double-blind phase 2 randomized controlled trial comparing psylocibin to escitalopram, a traditional SSRI, Nutt found the latter didn't spark the same magic."The SSRI did not increase brain connectivity, and it actually did not improve well-being as much as psilocybin," Nutt said. "Now for the first time you've got the brain science lining up with what patients say after a trip: 'I feel more connected. I can think more freely. I can escape from negative thoughts, and I don't get trapped in them.' "Taking a psychedelic doesn't work for everyone, Johnson stressed, "but when it works really well it's like, 'Oh my god, it's a cure for PTSD or for depression.' If people really have changed the way their brain is automatically hardwired to respond to triggers for anxiety, depression, smoking -- that's a real thing."How long do results last? In studies where patients were given just one dose of a psychedelic "a couple of people were better eight years later, but for the majority of those with chronic depression it creeps back after four or five months," Nutt said."What we do with those people is unknown," he added. "One possibility is to give another dose of the psychedelic -- we don't know if that would work or not, but it might. Or we could put them on an SSRI as soon as they've got their mood improved and see if that can hold the depression at bay."There are all sorts of ways we could try to address that question," Nutt said, "but we just don't know the answer yet."What about microdosing?Stamets, who over the last 40 years has discovered four new species of psychedelic mushrooms and written seven books on the topic, said he believes microdosing is a solution. That's the practice of taking tiny amounts of a psilocybin mushroom several times a week to maintain brain health and a creative perspective on life.A typical microdose is .01 to .03 grams of dried psilocybin mushrooms, as compared to the 25-milligram pill of psilocybin that creates the full-blown psychedelic experience.Stamets practices microdosing, and has focused on a process called "stacking," in which a microdose of mushrooms is taken with additional substances believed to boost the fungi's benefits. His famous "Stamets Stack" includes niacin, or vitamin B3, and the mycelium, or rootlike structure, of an unusual mushroom called Lion's mane.Surveys of microdosers obtained on his website have shown significantly positive benefits from the practice of taking small doses."These are self-reported citizen scientists projects and we have now around 14,000 people in our app where you register yourself and report your microdose," Stamets told an audience at the 2022 Life Itself conference, a health and wellness event presented in partnership with CNN."I'm going to say something provocative, but I believe it to my core: Psilocybin makes nicer people," Stamets told the audience. "Psilocybin will make us more intelligent, and better citizens."Video below: Psychedelic drugs may improve your cardiovascular healthScientific studies so far have failed to find any benefits from microdosing, leaving many researchers skeptical. "People like being on it, but that doesn't validate the claims of microdosing," Johnson said. "People like being on a little bit of cocaine, too."Experimental psychologist Harriet de Wit, a professor of psychiatry and behavioral science at the University of Chicago, was excited to study microdosing because it solves a key problem of scientific research in the field -- it's hard to blind people to what they are taking if they begin to trip. Microdosing solves that problem because people don't feel an effect from the tiny dose.De Wit specializes in determining whether a drug's impact is due to the drug or what scientists call the "placebo effect," a positive expectation that can cause improvement without the drug.She published a study in early 2022 that mimicked real-world microdosing of LSD, except neither the participants nor researchers knew what was in the pills the subjects took."We measured all kinds of different behavioral and psychological responses, and the only thing we saw is that LSD at very low doses produced some stimulant-like effects at first, which then faded," de Wit said.The placebo effect is powerful, she added, which might explain why the few additional studies done on it have also failed to find any positive results."I suspect microdosing may have an effect on mood, and over time it might build up resilience or improve well-being," Nutt said. "But I don't think it will rapidly fragment depression like macrodosing and going on a trip."A need for cautionObviously, not all hallucinogenic experiences are positive, so nearly every study on psychedelic drugs has included therapists trained to intercede if a trip turns bad and maximize the outcome if the trip is good."This is about allowing someone access into deeper access into their own mental processes, with hopefully greater insight. While others might disagree, it does seem very clear that you need therapy to maximize the benefits," Johnson said.There are also side effects from psychedelics that go beyond a bad trip. LSD, mescaline and DMT, which is the active ingredient in ayahuasca tea, can increase blood pressure, heart rate, and body temperature, according to the National Institute on Drug Abuse. Ayahuasca tea can also induce vomiting. LSD can cause tremors, numbness and weakness, while the use of mescaline can lead to uncoordinated movements. People hunting for psychedelic mushrooms can easily mistake a toxic species for one with psilocybin, "leading to unintentional, fatal poisoning."Another issue: Not everyone is a candidate for psychedelic treatment. It won't work on people currently on SSRIs -- the receptors in their brains are already flooded with serotonin. People diagnosed with bipolar disorder or schizophrenia, or who have a family history of psychosis are always screened out of clinical trials, said Frederick Barrett, associate director of the Center for Psychedelic and Consciousness Research at Johns Hopkins."If you have a vulnerability to psychosis, it could be that exposing you to a psychedelic could unmask that psychosis or could lead to a psychotic event," Barnes said.Then there are the thousands of people with mental health concerns who will never agree to undergo a psychedelic trip. For those people, scientists such as Roth are attempting to find an alternative approach. He and his team recently identified the mechanisms by which psychedelics bond to the brain's serotonin receptors and are using the knowledge to identify new compounds."Our hope is that we can use this information to ultimately make drugs that mimic the benefits of psychedelic drugs without the psychedelic experience," Roth said."What if we could give people who are depressed or suffer from PTSD or anxiety or obsessive-compulsive disorder a medication, and they could wake up the next day and be fine without any side effects? That would be transformative."

Shrooms, Alice, tweezes, mushies, hongos, pizza toppings, magic mushrooms -- everyday lingo for psychedelic mushrooms seems to grow with each generation. Yet leading mycologist Paul Stamets believes it's time for fans of psilocybin mushrooms to leave such childish slang behind.

"Let's be adults about this. These are no longer 'shrooms.' These are no longer party drugs for young people," Stamets told CNN. "Psilocybin mushrooms are non-addictive, life-changing substances."

Small clinical trials that have shown that one or two doses of psylocibin, given in a therapeutic setting, can make dramatic and long-lasting changes in people suffering from treatment-resistant major depressive disorder, which typically does not respond to traditional antidepressants.

Based on this research, the U.S. Food and Drug Administration has described psilocybin as a breakthrough medicine, "which is phenomenal," Stamets said.

Psilocybin, which the intestines convert into psilocin, a chemical with psychoactive properties, is also showing promise in combating cluster headaches, anxiety, anorexia, obsessive-compulsive disorder and various forms of substance abuse.

"The data are strong from depression to PTSD to cluster headaches, which is one of the most painful conditions I'm aware of," said neurologist Richard Isaacson, director of the Alzheimer's Prevention Clinic in the Center for Brain Health at Florida Atlantic University.

"I'm excited about the future of psychedelics because of the relatively good safety profile and because these agents can now be studied in rigorous double-blinded clinical trials," Isaacson said. "Then we can move from anecdotal reports of 'I tripped on this and felt better' to 'Try this and you will be statistically, significantly better.'"

Classic psychedelics such as psilocybin and LSD enter the brain via the same receptors as serotonin, the body's "feel good" hormone. Serotonin helps control body functions such as sleep, sexual desire and psychological states such as satisfaction, happiness and optimism.

People with depression or anxiety often have low levels of serotonin, as do people with post-traumatic stress disorder, cluster headaches, anorexia, smoking addiction and substance abuse. Treatment typically involves selective serotonin reuptake inhibitors, or SSRIs, which boost levels of serotonin available to brain cells. Yet it can take weeks for improvement to occur, experts say, if the drugs even work at all.

farmer images

With psychedelics such as psilocybin and LSD, however, scientists can see changes in brain neuron connectivity in the lab "within 30 minutes," said pharmacologist Brian Roth, a professor of psychiatry and pharmacology at the University of North Carolina at Chapel Hill.

"One of the most interesting things we've learned about the classic psychedelics is that they have a dramatic effect on the way brain systems synchronize, or move and groove together," said Matthew Johnson, a professor in psychedelics and consciousness at Johns Hopkins Medicine.

"When someone's on psilocybin, we see an overall increase in connectivity between areas of the brain that don't normally communicate well," Johnson said. "You also see the opposite of that -- local networks in the brain that normally interact with each other quite a bit suddenly communicate less."

It creates a "very, very disorganized brain," ultimately breaking down normal boundaries between the auditory, visual, executive and sense-of-self sections of the mind -- thus creating a state of "altered consciousness," said David Nutt, director of the Neuropsychopharmacology Unit in the Division of Brain Sciences at Imperial College London.

And it's that disorganization that is ultimately therapeutic, according to Nutt: "Depressed people are continually self-critical, and they keep ruminating, going over and over the same negative, anxious or fearful thoughts.

"Psychedelics disrupt that, which is why people can suddenly see a way out of their depression during the trip," he added. "Critical thoughts are easier to control, and thinking is more flexible. That's why the drug is an effective treatment for depression."

There's more. Researchers say psychedelic drugs actually help neurons in the brain sprout new dendrites, which look like branches on a tree, to increase communication between cells.

"These drugs can increase neuronal outgrowth, they can increase this branching of neurons, they can increase synapses. That's called neuroplasticity," Nutt said.

That's different from neurogenesis, which is the development of brand new brain cells, typically from stem cells in the body. The growth of dendrites helps build and then solidify new circuits in the brain, allowing us to, for example, lay down more positive pathways as we practice gratitude.

"Now our current thinking is this neuronal outgrowth probably doesn't contribute to the increased connectivity in the brain, but it almost certainly helps people who have insights into their depression while on psilocybin maintain those insights," Nutt said.

"You shake up the brain, you see things in a more positive way, and then you lay down those positive circuits with the neuroplasticity," he added. "It's a double whammy."

Interestingly, SSRIs also increase neuroplasticity, a fact that science has known for some time. But in a 2022 double-blind phase 2 randomized controlled trial comparing psylocibin to escitalopram, a traditional SSRI, Nutt found the latter didn't spark the same magic.

"The SSRI did not increase brain connectivity, and it actually did not improve well-being as much as psilocybin," Nutt said. "Now for the first time you've got the brain science lining up with what patients say after a trip: 'I feel more connected. I can think more freely. I can escape from negative thoughts, and I don't get trapped in them.' "

Taking a psychedelic doesn't work for everyone, Johnson stressed, "but when it works really well it's like, 'Oh my god, it's a cure for PTSD or for depression.' If people really have changed the way their brain is automatically hardwired to respond to triggers for anxiety, depression, smoking -- that's a real thing."

How long do results last? In studies where patients were given just one dose of a psychedelic "a couple of people were better eight years later, but for the majority of those with chronic depression it creeps back after four or five months," Nutt said.

"What we do with those people is unknown," he added. "One possibility is to give another dose of the psychedelic -- we don't know if that would work or not, but it might. Or we could put them on an SSRI as soon as they've got their mood improved and see if that can hold the depression at bay.

"There are all sorts of ways we could try to address that question," Nutt said, "but we just don't know the answer yet."

Stamets, who over the last 40 years has discovered four new species of psychedelic mushrooms and written seven books on the topic, said he believes microdosing is a solution. That's the practice of taking tiny amounts of a psilocybin mushroom several times a week to maintain brain health and a creative perspective on life.

Courtesy Pamela Kryskow

A typical microdose is .01 to .03 grams of dried psilocybin mushrooms, as compared to the 25-milligram pill of psilocybin that creates the full-blown psychedelic experience.

Stamets practices microdosing, and has focused on a process called "stacking," in which a microdose of mushrooms is taken with additional substances believed to boost the fungi's benefits. His famous "Stamets Stack" includes niacin, or vitamin B3, and the mycelium, or rootlike structure, of an unusual mushroom called Lion's mane.

Surveys of microdosers obtained on his website have shown significantly positive benefits from the practice of taking small doses.

"These are self-reported citizen scientists projects and we have now around 14,000 people in our app where you register yourself and report your microdose," Stamets told an audience at the 2022 Life Itself conference, a health and wellness event presented in partnership with CNN.

"I'm going to say something provocative, but I believe it to my core: Psilocybin makes nicer people," Stamets told the audience. "Psilocybin will make us more intelligent, and better citizens."

Video below: Psychedelic drugs may improve your cardiovascular health

Scientific studies so far have failed to find any benefits from microdosing, leaving many researchers skeptical. "People like being on it, but that doesn't validate the claims of microdosing," Johnson said. "People like being on a little bit of cocaine, too."

Experimental psychologist Harriet de Wit, a professor of psychiatry and behavioral science at the University of Chicago, was excited to study microdosing because it solves a key problem of scientific research in the field -- it's hard to blind people to what they are taking if they begin to trip. Microdosing solves that problem because people don't feel an effect from the tiny dose.

De Wit specializes in determining whether a drug's impact is due to the drug or what scientists call the "placebo effect," a positive expectation that can cause improvement without the drug.

She published a study in early 2022 that mimicked real-world microdosing of LSD, except neither the participants nor researchers knew what was in the pills the subjects took.

"We measured all kinds of different behavioral and psychological responses, and the only thing we saw is that LSD at very low doses produced some stimulant-like effects at first, which then faded," de Wit said.

The placebo effect is powerful, she added, which might explain why the few additional studies done on it have also failed to find any positive results.

"I suspect microdosing may have an effect on mood, and over time it might build up resilience or improve well-being," Nutt said. "But I don't think it will rapidly fragment depression like macrodosing and going on a trip."

Obviously, not all hallucinogenic experiences are positive, so nearly every study on psychedelic drugs has included therapists trained to intercede if a trip turns bad and maximize the outcome if the trip is good.

"This is about allowing someone access into deeper access into their own mental processes, with hopefully greater insight. While others might disagree, it does seem very clear that you need therapy to maximize the benefits," Johnson said.

There are also side effects from psychedelics that go beyond a bad trip. LSD, mescaline and DMT, which is the active ingredient in ayahuasca tea, can increase blood pressure, heart rate, and body temperature, according to the National Institute on Drug Abuse. Ayahuasca tea can also induce vomiting. LSD can cause tremors, numbness and weakness, while the use of mescaline can lead to uncoordinated movements. People hunting for psychedelic mushrooms can easily mistake a toxic species for one with psilocybin, "leading to unintentional, fatal poisoning."

Another issue: Not everyone is a candidate for psychedelic treatment. It won't work on people currently on SSRIs -- the receptors in their brains are already flooded with serotonin. People diagnosed with bipolar disorder or schizophrenia, or who have a family history of psychosis are always screened out of clinical trials, said Frederick Barrett, associate director of the Center for Psychedelic and Consciousness Research at Johns Hopkins.

"If you have a vulnerability to psychosis, it could be that exposing you to a psychedelic could unmask that psychosis or could lead to a psychotic event," Barnes said.

Then there are the thousands of people with mental health concerns who will never agree to undergo a psychedelic trip. For those people, scientists such as Roth are attempting to find an alternative approach. He and his team recently identified the mechanisms by which psychedelics bond to the brain's serotonin receptors and are using the knowledge to identify new compounds.

"Our hope is that we can use this information to ultimately make drugs that mimic the benefits of psychedelic drugs without the psychedelic experience," Roth said.

"What if we could give people who are depressed or suffer from PTSD or anxiety or obsessive-compulsive disorder a medication, and they could wake up the next day and be fine without any side effects? That would be transformative."

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How psilocybin, the psychedelic in mushrooms, may rewire the brain to ease depression, anxiety - WYFF4 Greenville

Newswise CHICAGO (June 10, 2022): Anthony Atala, MD, FACS, Winston-Salem, North Carolina, will be presented with the 2022 Jacobson Innovation Award of the American College of Surgeons (ACS) at a dinner held in his honor this evening in Chicago. He is currently the George Link, Jr. Professor and Director of the Wake Forest Institute for Regenerative Medicine (WFIRM) and the W. H. Boyce Professor and Chair of Urology at the Wake Forest University School of Medicine.

The international surgical award from the ACS honors living surgeons who are innovators of a new development or technique in any field of surgery. It is made possible through a gift from Julius H. Jacobson II, MD, FACS, and his wife Joan. Dr. Jacobson is a general vascular surgeon known for his pioneering work in the development of microsurgery.

Dr. Atala is a pediatric urologist, researcher, professor, and mentor who is renowned for developing foundational principles for regenerative medicine research, which holds great promise for people who require tissue substitution and reconstruction. Dr. Atala and his team successfully implanted the worlds first laboratory grown bladder in 1999.

Dr. Atalas remarkable work has expanded, and today, WFIRM is a leader in translating scientific discovery into regenerative medicine clinical therapies. He currently leads an interdisciplinary team of more than 450 researchers and physicians. Beyond many other world firsts, WFIRM has also developed 15 clinically used technology-based applications, including muscle, urethra, cartilage, reproductive tissues, and skin. Currently, the Institute is working on more than 40 tissues and organs.

Through Dr. Atala's vision, ingenuity, and leadership, the WFIRM team has developed specialized 3-D printers to engineer tissues. This work is accomplished by using cells to create various tissues and organs, including miniature organs called organoids to create body-on-a-chip systems. Dr. Atala and his team also discovered a stem cell population derived from both the amniotic fluid and the placenta, which are currently being used for clinically relevant research applications.

Dr. Atala's theory is that every cell within the human body should be capable of regeneration. What reproduces naturally inside the body should also have the same capabilities of reproduction outside of the body. According to Dr. Atala, the key benefit to the approach of cell and tissue regeneration is that a patient will not reject their own cells or tissue, which is always a concern related to traditional organ match transplantation.

Honors and awards Dr. Atalas innovative work has been recognized as one of Time magazine's Top 10 Medical Breakthroughs in 2007, Smithsonian's 2010 Top Science Story of the Year, and U.S. News & World Report's honor as one of 14 top Pioneers of Medical Progress in the 21st Century. He has been named by Scientific American as one of the world's most influential people in biotechnology, by Life Sciences Intellectual Property Review as one of 50 Key Influencers in the Life Sciences Intellectual Property arena, and by Nature Biotechnology as one of the top 10 Translational Researchers in the World.

Dr. Atala was elected to the Institute of Medicine of the National Academies of Sciences (now the National Academy of Medicine) in 2011 and inducted into the American Institute for Medical and Biological Engineering. In 2014, he was inducted into the National Academy of Inventors as a Charter Fellow and has been a strong and thoughtful contributor to the ACS Surgical Forum and Surgical Research Committee. He presented the prestigious Martin Memorial Named Lecture during the ACS Clinical Congress in 2010 entitled, Regenerative Medicine: New Approaches to Health Care.

Other honors include being the recipient of the U.S. Congress-funded Christopher Columbus Foundation Award, which is bestowed on a living American that currently is working on a discovery that will significantly affect society; the World Technology Award in Health and Medicine for achieving significant and lasting progress; the Edison Science/Medical Award; and the Smithsonian Ingenuity Award.

A national leader in regenerative medicine Throughout his distinguished career, Dr. Atala has led or served on several national professional and government committees, including the National Institutes of Health Working Group on Cells and Developmental Biology, the National Institutes of Health Bioengineering Consortium, and the National Cancer Institute's Advisory Board. He is a founder of the Tissue Engineering Society, the Regenerative Medicine Society, the Regenerative Medicine Foundation, the Alliance for Regenerative Medicine, the Regenerative Medicine Development Organization, the Regenerative Medicine Manufacturing Society, and the Regenerative Medicine Manufacturing Consortium.

A prolific author and inventorDr. Atala is the editor in chief of Stem Cells-Translational Medicine and BioPrinting. He is an author or coauthor of more than 800 journal articles and has applied for or received over 250 national and international patents.

# # #

About Anthony Atala, MD, FACS

Dr. Atala was born in Lima, Peru, and moved to the United States with his family when he was a young boy. He earned a Bachelor of Arts degree from the University of Miami before attending medical school at the University of Louisville, where he also completed his surgical residency training. Near the end of his residency, he applied for a pediatric urology fellowship at Boston Children's Hospital, which was transitioning from a one-year to a two-year program to include a year of research prior to the clinical year. He embarked on a fellowship there in its new form with encouragement from Alan B. Retik, MD, FACS, founder of Boston Childrens first department of urology. Dr. Atala arrived in Boston and began attending seminars, which led him to explore whether uroepithelial cells could be grown and expanded ex vivo, comparable to skin. This additional year of research sparked what has become his career of transformational research, discovery, and innovation with his work focused on growing human cells, tissues, and organs.

Dr. Atala spent the first portion of his academic career at Harvard Medical School before being recruited in 2004 as professor and chair of the department of urology at Wake Forest School of Medicine. After moving his laboratory from Boston, he became the founding Director of the Wake Forest Institute for Regenerative Medicine, where his research and work has produced extraordinary results for nearly two decades.

About the American College of Surgeons The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for all surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 84,000 members and is the largest organization of surgeons in the world. "FACS" designates that a surgeon is a Fellow of the American College of Surgeons.

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Pediatric Urologist Dr. Anthony Atala to Receive 2022 Jacobson Innovation Award of the American College of Surgeons for Pioneering Work in...

The soybean (Glycine max) is native to East Asia and has been grown for thousands of years. Soybean plants are on average 3 to 5 feet tall and can have up to 20 nodes. The plant has the ability to produce 600 pods per plant, but on average there are 50 to 100 pods per plant that set seed. Each pod contains on average three seed. Soybean yields are directly dependent on the number of plants per acre, the number of pods per plant, the number of seeds per pod, and the size of the seed.

Soybean varieties are classified based on their requirement to initiate reproductive development and their morphological growth habit. Soybeans are photoperiod sensitive, short-day plants, meaning that days must be shorter than a critical value to induce flowering. Soybean varieties are classified into maturity groups according to their response to photoperiod. Soybean varieties are also classified based on their growth habit. In varieties with a determinate growth habit, the onset of reproductive growth results in the termination of vegetative growth. Indeterminate varieties, however, start flowering several weeks before they terminate vegetative growth. Most Southern varieties are determinate, while most Midwest varieties are indeterminate.

Soybeans are legumes and, like most other legumes, have the ability to supply their own nitrogen. Nitrogen fixation begins with the formation of a nodule on the root. Nodules are produced from Bradyrhizobia bacteria in the soil that invade the root and multiply within the root cells. The soybean plant supplies the bacteria with nutrients and energy, and in return the bacteria convert atmospheric nitrogen (N2) in the air to nitrates (N03-) the plant can then use.

Understanding how soybeans grow and develop is critical to effectively managing the crop for increasing yields.

A descriptive system has been developed to describe the growth stage of a soybean plant. The system most commonly used was developed by W.R. Fehr and C.E. Caviness in 1977. Understanding and being familiar with soybean growth stages are useful when discussing proper management throughout the year. Soybean development can be divided into vegetative (V) and reproductive (R) stages (Table 1-1). Each stage starts when at least 50% of plants in that field are at that stage.

The vegetative stages begin with emergence (VE), which occurs when elongation of the hypocotyl brings the cotyledons out of the soil. After emergence, a pair of unifoliate leaves on the first node unroll just above the cotyledons and start the VC stage. Following VC, trifoliate leaves begin to unfold. The number of nodes with the trifoliate leaf fully developed and unrolled is referred to as V(n). A leaf is considered fully developed when the leaf at the node directly above it has expanded enough that the edges of the leaflets are not touching. The vegetative stages proceed from V1 through V(n).

The reproductive stages begin when the first flower is present on the plant (R1). The first flower is typically toward the bottom of the plant. As the plant moves into full bloom, it enters into R2. The reproductive stages include pod development (R3 and R4), seed development (R5 and R6), and finally maturity (R7 and R8).

Stage

Stage No.

Abbreviated Stage Title

Description

Image

Vegetative Stages

VE

Emergence

Cotyledons above the soil surface.

VE growth stage

VC

Cotyledon

Unifoliate leaves unrolled sufficiently so the leaf edges are not touching.

VC growth stage

V1

First-node

Fully developed leaves at unifoliate nodes.

V1 growth stage

V2

Second-node

Full developed trifoliate leaf at node above the unifoliate nodes.

V2 growth stage

V(n)

nth-node

n number of nodes on the main stem with fully developed leaves beginning with the unifoliate nodes. n can be any number beginning with 1 for V1, first- node stage.

V(n) growth stage

Reproductive Stages

R1

Beginning bloom

One open flower at any node on the main stem.

R1 growth stage

R2

Full bloom

Open flower at one of the two uppermost nodes on the main stem with a fully developed leaf.

R2 growth stage

R3

Beginning pod

Pod 5 mm (3/16) long at one of the four uppermost nodes on the main stem with a fully developed leaf.

R3 growth stage

R4

Full pod

Pod 2 cm (3/4) long at one of the four uppermost nodes on the main stem with a fully developed leaf.

R4 growth stage

R5

Beginning seed

Seed 3 mm (1/8) long in a pod at one of the four uppermost nodes on the main stem with a fully develop leaf.

R5 growth stage

R6

Full seed

Pod containing a green seed that fills the pod cavity at one of the four uppermost nodes on the main stem with a fully developed leaf.

R6 growth stage

R7

Beginning maturity

One normal pod on the main stem that has reached its mature pod color.

R7 growth stage

R8

Full maturity

95% of the pods that have reached their mature pod color. 5 to 10 days of drying weather are required after R8 before the soybeans have less than 15% moisture.

R8 growth stage

The descriptions focus on the top of the soybean plant, so they are applicable to both determinate and indeterminate varieties. Some of the stage descriptions may seem awkward, but they were intentionally chosen to be interpreted the same by most, if not all, users. The most ambiguous of these stages is R7, which was originally intended to identify physiological maturity. While physiological maturity (when dry matter accumulation ceases) is fairly easy to determine in other crops, its more difficult in soybeans. There is no obvious visible signal that indicates physiological maturity has been reached, but Fehr and Cavinesss description works fairly well for determinate varieties in the South.

The number of days between stages varies depending on the maturity group and variety planted, but there are a few trends that usually hold true.

Soybean development is also influenced by temperature, day length, soil moisture, and other environmental conditions. Therefore, the timing of growth stages will be different for different varieties, planting dates, and climates.

VE growth stage.

VC growth stage.

V1 growth stage.

V2 growth stage.

R1 growth stage.

R2 growth stage.

R3 growth stage.

R4 growth stage.

R5 growth stage.

R6 growth stage.

R7 growth stage.

R8 growth stage.

Soybeans were first classified into maturity groups (MGs) in the early 1900s. Today there are 13 major groups ranging from MG 000 to MG X, with lower-numbered maturity groups representing earlier maturing varieties. These groupings were based on adaptation within certain latitudes. A variety is classified to a specific MG according to the length of time from planting to maturity. Maturity group belts run east to west in North America. Historically, lower number MGs were grown in the extreme northern United States and Canada, and they progressively got higher as you moved south to the Gulf Coast states.

The most recent classification of MGs was carried out in 2017 by Mourtzinis and Conley (Figure 1-1) by aggregating MG-specific yield data from variety performance trials across the United States. Data were collected from 27 states over a period of 14 years to develop the MG zones.

Figure 1-1 shows that most of North Carolina is in the group V zone. This implies that a group V variety would be considered a mid-season variety for most of the state. A group IV variety would be considered an early-season variety, and a group VII variety would be considered a late-season variety. Most of the state could grow all three maturity groups successfully.

Because of soybeans ability to adapt to a wide range of conditions and North Carolinas flexibility in planting date, varieties with maturity group designations outside of the optimal range can still be grown. North Carolina growers successfully plant a range of maturity groups from late III's to early VIII's.

Typically, varieties in earlier maturing groups develop fewer leaves and reach R1 earlier. This means a group V will mature and quit growing earlier than a group VI will, if planted at the same time. Historically, group IV and earlier maturing varieties are indeterminate in growth habit, while group V and later maturing varieties are determinate varieties; but recently, later maturing indeterminate varieties have been released. Whether one growth habit is an advantage or a disadvantage, compared to the other, is arguable.

Each major maturity group is further divided 10 times to designate the relative maturity rating for a soybean variety. The relative maturity is expressed as a decimal. For example, a 4.1 will mature earlier than a 4.7 even though they are in the same major maturity group. Most seed companies use the relative maturity rating to classify their varieties.

Figure 1-1. Soybean maturity zone map of the United States. Data from Mourtzinis, S., and S. Conley. (2017). "Delineating soybean maturity groups across the United States." Agronomy Journal 109: 1-7. 10.2134/agronj2016.10.0581

Find more information at the following NC State Extension websites:

Publication date: Jan. 6, 2022AG-835

Recommendations for the use of agricultural chemicals are included in this publication as a convenience to the reader. The use of brand names and any mention or listing of commercial products or services in this publication does not imply endorsement by NC State University or N.C. A&T State University nor discrimination against similar products or services not mentioned. Individuals who use agricultural chemicals are responsible for ensuring that the intended use complies with current regulations and conforms to the product label. Be sure to obtain current information about usage regulations and examine a current product label before applying any chemical. For assistance, contact your local N.C. Cooperative Extension county center.

N.C. Cooperative Extension prohibits discrimination and harassment regardless of age, color, disability, family and marital status, gender identity, national origin, political beliefs, race, religion, sex (including pregnancy), sexual orientation and veteran status.

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The Soybean Plant | NC State Extension Publications

Brian Sheltons life was ruled by Type 1 diabetes.

When his blood sugar plummeted, he would lose consciousness without warning. He crashed his motorcycle into a wall. He passed out in a customers yard while delivering mail. Following that episode, his supervisor told him to retire, after a quarter century in the Postal Service. He was 57.

His ex-wife, Cindy Shelton, took him into her home in Elyria, Ohio. I was afraid to leave him alone all day, she said.

Early this year, she spotted a call for people with Type 1 diabetes to participate in a clinical trial by Vertex Pharmaceuticals. The company was testing a treatment developed over decades by a scientist who vowed to find a cure after his baby son and then his teenage daughter got the devastating disease.

Mr. Shelton was the first patient. On June 29, he got an infusion of cells, grown from stem cells but just like the insulin-producing pancreas cells his body lacked.

Now his body automatically controls its insulin and blood sugar levels.

Mr. Shelton, now 64, may be the first person cured of the disease with a new treatment that has experts daring to hope that help may be coming for many of the 1.5 million Americans suffering from Type 1 diabetes.

Its a whole new life, Mr. Shelton said. Its like a miracle.

Diabetes experts were astonished but urged caution. The study is continuing and will take five years, involving 17 people with severe cases of Type 1 diabetes. It is not intended as a treatment for the more common Type 2 diabetes.

Weve been looking for something like this to happen literally for decades, said Dr. Irl Hirsch, a diabetes expert at the University of Washington who was not involved in the research. He wants to see the result, not yet published in a peer-reviewed journal, replicated in many more people. He also wants to know if there will be unanticipated adverse effects and if the cells will last for a lifetime or if the treatment would have to be repeated.

But, he said, bottom line, it is an amazing result.

Dr. Peter Butler, a diabetes expert at U.C.L.A. who also was not involved with the research, agreed while offering the same caveats.

It is a remarkable result, Dr. Butler said. To be able to reverse diabetes by giving them back the cells they are missing is comparable to the miracle when insulin was first available 100 years ago.

And it all started with the 30-year quest of a Harvard University biologist, Doug Melton.

Dr. Melton had never thought much about diabetes until 1991 when his 6-month-old baby boy, Sam, began shaking, vomiting and panting.

He was so sick, and the pediatrician didnt know what it was, Dr. Melton said. He and his wife Gail OKeefe rushed their baby to Boston Childrens Hospital. Sams urine was brimming with sugar a sign of diabetes.

The disease, which occurs when the bodys immune system destroys the insulin-secreting islet cells of the pancreas, often starts around age 13 or 14. Unlike the more common and milder Type 2 diabetes, Type 1 is quickly lethal unless patients get injections of insulin. No one spontaneously gets better.

Its a terrible, terrible disease, said Dr. Butler at U.C.L.A.

Patients are at risk of going blind diabetes is the leading cause of blindness in this country. It is also the leading cause of kidney failure. People with Type 1 diabetes are at risk of having their legs amputated and of death in the night because their blood sugar plummets during sleep. Diabetes greatly increases their likelihood of having a heart attack or stroke. It weakens the immune system one of Dr. Butlers fully vaccinated diabetes patients recently died from Covid-19.

Added to the burden of the disease is the high cost of insulin, whose price has risen each year.

The only cure that has ever worked is a pancreas transplant or a transplant of the insulin-producing cell clusters of the pancreas, known as islet cells, from an organ donors pancreas. But a shortage of organs makes such an approach an impossibility for the vast majority with the disease.

Even if we were in utopia, we would never have enough pancreases, said Dr. Ali Naji, a transplant surgeon at the University of Pennsylvania who pioneered islet cell transplants and is now a principal investigator for the trial that treated Mr. Shelton.

For Dr. Melton and Ms. OKeefe, caring for an infant with the disease was terrifying. Ms. OKeefe had to prick Sams fingers and feet to check his blood sugar four times a day. Then she had to inject him with insulin. For a baby that young, insulin was not even sold in the proper dose. His parents had to dilute it.

Gail said to me, If Im doing this you have to figure out this damn disease, Dr. Melton recalled. In time, their daughter Emma, four years older than Sam, would develop the disease too, when she was 14.

Dr. Melton had been studying frog development but abandoned that work, determined to find a cure for diabetes. He turned to embryonic stem cells, which have the potential to become any cell in the body. His goal was to turn them into islet cells to treat patients.

One problem was the source of the cells they came from unused fertilized eggs from a fertility clinic. But in August 2001, President George W. Bush barred using federal money for research with human embryos. Dr. Melton had to sever his stem cell lab from everything else at Harvard. He got private funding from the Howard Hughes Medical Institute, Harvard and philanthropists to set up a completely separate lab with an accountant who kept all its expenses separate, down to the light bulbs.

Over the 20 years it took the lab of 15 or so people to successfully convert stem cells into islet cells, Dr. Melton estimates the project cost about $50 million.

The challenge was to figure out what sequence of chemical messages would turn stem cells into insulin-secreting islet cells. The work involved unraveling normal pancreatic development, figuring out how islets are made in the pancreas and conducting endless experiments to steer embryonic stem cells to becoming islets. It was slow going.

After years when nothing worked, a small team of researchers, including Felicia Pagliuca, a postdoctoral researcher, was in the lab one night in 2014, doing one more experiment.

We werent very optimistic, she said. They had put a dye into the liquid where the stem cells were growing. The liquid would turn blue if the cells made insulin.

Her husband had already called asking when was she coming home. Then she saw a faint blue tinge that got darker and darker. She and the others were ecstatic. For the first time, they had made functioning pancreatic islet cells from embryonic stem cells.

The lab celebrated with a little party and a cake. Then they had bright blue wool caps made for themselves with five circles colored red, yellow, green, blue and purple to represent the stages the stem cells had to pass through to become functioning islet cells. Theyd always hoped for purple but had until then kept getting stuck at green.

The next step for Dr. Melton, knowing hed need more resources to make a drug that could get to market, was starting a company.

His company Semma was founded in 2014, a mix of Sam and Emmas names.

One challenge was to figure out how to grow islet cells in large quantities with a method others could repeat. That took five years.

The company, led by Bastiano Sanna, a cell and gene therapy expert, tested its cells in mice and rats, showing they functioned well and cured diabetes in rodents.

At that point, the next step a clinical trial in patients needed a large, well financed and experienced company with hundreds of employees. Everything had to be done to the exacting standards of the Food and Drug Administration thousands of pages of documents prepared, and clinical trials planned.

Chance intervened. In April 2019, at a meeting at Massachusetts General Hospital, Dr. Melton ran into a former colleague, Dr. David Altshuler, who had been a professor of genetics and medicine at Harvard and the deputy director of the Broad Institute. Over lunch, Dr. Altshuler, who had become the chief scientific officer at Vertex Pharmaceuticals, asked Dr. Melton what was new.

Dr. Melton took out a small glass vial with a bright purple pellet at the bottom.

These are islet cells that we made at Semma, he told Dr. Altshuler.

Vertex focuses on human diseases whose biology is understood. I think there might be an opportunity, Dr. Altshuler told him.

Meetings followed and eight weeks later, Vertex acquired Semma for $950 million. With the acquisition, Dr. Sanna became an executive vice president at Vertex.

The company will not announce a price for its diabetes treatment until it is approved. But it is likely to be expensive. Like other companies, Vertex has enraged patients with high prices for drugs that are difficult and expensive to make.

Vertexs challenge was to make sure the production process worked every time and that the cells would be safe if injected into patients. Employees working under scrupulously sterile conditions monitored vessels of solutions containing nutrients and biochemical signals where stem cells were turning into islet cells.

Less than two years after Semma was acquired, the F.D.A. allowed Vertex to begin a clinical trial with Mr. Shelton as its initial patient.

Like patients who get pancreas transplants, Mr. Shelton has to take drugs that suppress his immune system. He says they cause him no side effects, and he finds them far less onerous or risky than constantly monitoring his blood sugar and taking insulin. He will have to continue taking them to prevent his body from rejecting the infused cells.

But Dr. John Buse, a diabetes expert at the University of North Carolina who has no connection to Vertex, said the immunosuppression gives him pause. We need to carefully evaluate the trade-off between the burdens of diabetes and the potential complications from immunosuppressive medications.

Mr. Sheltons treatment, known as an early phase safety trial, called for careful follow-up and required starting with half the dose that would be used later in the trial, noted Dr. James Markmann, Mr. Sheltons surgeon at Mass General who is working with Vertex on the trial. No one expected the cells to function so well, he said.

The result is so striking, Dr. Markmann said, Its a real leap forward for the field.

Last month, Vertex was ready to reveal the results to Dr. Melton. He did not expect much.

I was prepared to give them a pep talk, he said.

Dr. Melton, normally a calm man, was jittery during what felt like a moment of truth. He had spent decades and all of his passion on this project. By the end of the Vertex teams presentation, a huge smile broke out on his face; the data were for real.

He left Vertex and went home for dinner with Sam, Emma and Ms. OKeefe. When they sat down to eat, Dr. Melton told them the results.

Lets just say there were a lot of tears and hugs.

For Mr. Shelton the moment of truth came a few days after the procedure, when he left the hospital. He measured his blood sugar. It was perfect. He and Ms. Shelton had a meal. His blood sugar remained in the normal range.

Mr. Shelton wept when he saw the measurement.

The only thing I can say is thank you.

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A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked.

Jasper Therapeutics

REDWOOD CITY, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (NASDAQ: JSPR), a biotechnology company focused on hematopoietic cell transplant therapies, today announced that updated data from the Companys ongoing study of JSP191 as single agent conditioning prior to allogeneic hematopoietic stem cell (HSC) re-transplant in patients with severe combined immunodeficiency (SCID) has been accepted for presentation as a late-breaking poster at the 2022 Clinical Immunology Society (CIS) Annual Meeting, to be held in Charlotte, North Carolina from March 31 to April 3, 2022.

Title: Update: Single-Agent Conditioning with Anti-CD117 Antibody JSP191 Shows Donor Engraftment, Nave Lymphocyte Production, and Clinical Benefit in Patients with Severe Combined Immunodeficiency (SCID)Date and Time: Friday, April 1, 2022, 1:00-2:00 p.m. ET

This updated data indicates that JSP191 at 0.6mg/kg can deplete blood stem cells, leading to long-term donor cell engraftment, immune reconstitution which positively affects the clinical status of SCID patients who suffer from poor T cell and negligible B cell immunity because they failed their first transplant, said Wendy Pang, MD, Ph.D., Senior Vice President of Research and Translational Medicine of Jasper Therapeutics. This population of SCID patients is largely without treatment options and rely on supportive therapies like life long IVIG to provide some level of immune protection. JSP191 based conditioning may provide these patients with the best chance of a safe and successful transplant and reconstituted immune system.

CIS attendees are the primary caregivers for the immune deficient patient population, we are pleased to be able to present this data at the 2022 CIS annual meeting, Ronald Martell, CEO of Jasper. We believe that with our successful clinical efforts, we are one step closer, and uniquely positioned to deliver a targeted non-genotoxic conditioning agent to patients with SCID.

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About JSP191

JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or genetically modified transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 100 healthy volunteers and patients. Three clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML), severe combined immunodeficiency (SCID) and Fanconi anemia are currently enrolling. The Company plans a new study of JSP191 as a second-line therapeutic in lower risk MDS patients in 2022 as well as to a pivotal study in MDS/AML transplant in early 2023. Enrollment in additional studies are planned in patients with sickle cell disease, chronic granulomatous disease and GATA2 MDS who are undergoing hematopoietic cell transplantation.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic hematopoietic cell transplants and gene therapies. In parallel, Jasper Therapeutics is advancing its preclinical mRNA engineered hematopoietic stem cell (eHSC) platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential long-term benefits of hematopoietic stem cells (HSC) engraftment following targeted single-agent JSP191 conditioning in the treatment of severe combined immunodeficiency (SCID) and Jaspers ability to potentially deliver a targeted non-genotoxic conditioning agent to patients with SCID. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jaspers product candidates; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that Jaspers product candidates may not be beneficial to patients or successfully commercialized; patients willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jaspers business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jaspers business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jaspers filings with the SEC. If any of these risks materialize or Jaspers assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jaspers assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:John Mullaly (investors)LifeSci Advisors617-429-3548jmullaly@lifesciadvisors.com

Jeet Mahal (investors)Jasper Therapeutics650-549-1403jmahal@jaspertherapeutics.com

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Jasper Therapeutics to Present Updated Data on JSP191 Conditioning in SCID Patients at the 2022 Clinical Immunology Society Annual Meeting - Yahoo...

NEW YORK, Nov. 16, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that it has signed a Sponsored Research Agreement with North Carolina State University ("NC State") to support the continued research and development of HT-KIT, a novel therapeutic for the treatment mast cell cancers.

(PRNewsfoto/Hoth Therapeutics Inc.)

The research will be led by Dr. Glenn Cruse, Assistant Professor, and will focus on characterizing the HT-KIT dose and dosing frequency for treatment of aggressive mastocytosis and mast cell neoplasms using humanized tumor mouse models. In addition, the research will expand therapeutic potential of HT-KIT for the treatment of other cancers where aberrant cKIT signaling contributes to the cancer progression, such as gastrointestinal stromal tumors (GIST) and acute myeloid leukemia (AML).

"We are pleased to announce the continuation of our development of HT-KIT after our earlier announcement of beginning API and drug product manufacturing," said Stefanie Johns, Chief Scientific Officer of Hoth Therapeutics, Inc. "We remain focused on pushing this important cancer therapeutic through to the clinic. The research conducted by Dr. Cruse and NC State will help direct the continued development and clinical planning of this potentially life-saving therapy."

About HT-KITHT-KIT is a new molecular entity (NME) under development for treatment of mast cell derived cancers and anaphylaxis. HT-KIT was developed Dr. Glenn Cruse, Assistant Professor at North Carolina State University. The HT-KIT drug is designed to more specifically target the receptor tyrosine kinase KIT in mast cells, which is required for the proliferation, survival and differentiation of bone marrow-derived hematopoietic stem cells. Mutations in the KIT pathway have been associated with several human cancers, such as gastrointestinal stromal tumors and mast cell-derived cancers (mast cell leukemia and mast cell sarcoma). Based on the initial proof-of-concept success, Hoth intends to initially target mast cell neoplasms for development of HT-KIT, which is a rare, aggressive cancer with poor prognosis. The same target, KIT, also plays a key role in mast cell-mediated anaphylaxis, a serious allergic reaction that is rapid in onset and may cause death. Anaphylaxis typically occurs after exposure to an external allergen that results in an immediate and severe immune response.

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About Hoth Therapeutics, Inc.Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. Hoth's pipeline development is focused to improve the quality of life for patients suffering from indications including atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, mast-cell derived cancers & anaphylaxis and pneumonia. Hoth has also entered into two different agreements to further the development of two therapeutic prospects to prevent or treat COVID-19. To learn more, please visit https://ir.hoththerapeutics.com/.

Forward-Looking StatementThis press release includes forward-looking statements based upon Hoth's current expectations which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; our intellectual property; our reliance on third party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section entitled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.

Investor Contact:LR Advisors LLCEmail: investorrelations@hoththerapeutics.comwww.hoththerapeutics.comPhone: (678) 570-6791

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Hoth Therapeutics Announces a Sponsored Research Agreement to Further Develop Novel mRNA Cancer Therapeutic HT-KIT - Yahoo Finance

AVENTURA, Fla. and NEW YORK, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Cytovia Therapeutics, Inc., a biopharmaceutical company developing allogeneic off-the-shelf gene-edited iNK (NK cells derived from iPSC) and CAR (Chimeric Antigen Receptor) Natural Killer (NK) cells derived from induced pluripotent stem cells (iPSCs) and Flex-NK cell engager multifunctional antibodies, and Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage gene-editing company employing its core technology to develop products based on gene-editing with a portfolio of allogeneic chimeric antigen receptor (CAR-)T cells in the field of immuno-oncology and gene-edited hematopoietic stem cells in other indications, announced today that they have expanded their collaboration of TALEN gene-edited iPSC-derived NK and CAR-NK cells to include new CAR target and development in China by Cytovias joint venture entity, CytoLynx Therapeutics.

The amended financial terms include an equity stake totaling $20 million in Cytovia stock as well as up to $805 million of development, regulatory, and sales milestones and single-digit royalty payments on the net sales of all partnered products commercialized by Cytovia.

We are pleased to expand the collaboration with Cellectis to enable Cytovia to develop iNK products that will leverage the high-precision of TALEN to perform gene-editing to minimize the risk of off-target effects and unlock the full potential of NK cells as a first line of defense against cancer. Cytovias internal research and development, and manufacturing teams are actively developing multiple gene-edited therapeutic candidates and optimizing our technology platform towards next generation products, said Dr. Daniel Teper, Chairman & CEO of Cytovia Therapeutics.

Cellectis is developing custom TALEN, which Cytovia uses to edit iPSCs. Cytovia is responsible for the differentiation and expansion of the gene-edited iPSC master cell bank into NK cells and is conducting the pre-clinical evaluation, clinical development, and commercialization of the mutually-agreed-upon selected therapeutic candidates. Cellectis is granting Cytovia a worldwide license under the patent rights over which Cellectis has the control in this field,including in China, enabling Cytovia to modify NK cells to address multiple gene-targets for therapeutic use in several cancer indications.

We are thrilled at the progress Cytovia has accomplished in the past year, said Dr. Andr Choulika, CEO of Cellectis. Cytovia has attracted a world-class scientific team and is advancing its clinical candidates in areas of significant unmet medical need, sharing Cellectis mission to provide life-saving off-the-shelf allogeneic cell therapy to patients.

About Cytovia Therapeutics Cytovia Therapeutics aims to accelerate patient access to transformational cell therapies and immunotherapies, addressing several of the most challenging unmet medical needs in cancer.

Cytovia focuses on harnessing the innate immune system by developing complementary and disruptive NK-cell and NK-engager antibody platforms. It is developing three types of iPSC-derived (or iNK) cells: unedited iNK cells, TALEN gene-edited iNK cells with improved function and persistence, and TALEN gene-edited iNK cells with chimeric antigen receptors (CAR-iNKs) to improve tumor-specific targeting. The second complementary cornerstone technology is a quadrivalent multifunctional antibody platform designed to engage natural killer cells by targeting NKp46 using its proprietary Flex-NK technology.

These two technology platforms are being used to develop treatment of patients with solid tumors such as hepatocellular carcinoma (HCC) and glioblastoma as well as hematological malignancies such as refractory multiple myeloma.

Cytovias research and development laboratories in Natick, MA and GMP cell manufacturing facility in Puerto Rico are augmented by scientific partnerships with Cellectis, CytoImmune, the Hebrew University of Jerusalem, INSERM, the New York Stem Cell Foundation, and the University of California San Francisco (UCSF).

Cytovia Therapeutics has recently formedCytoLynxTherapeutics, ajoint-venture entity focused on research and development, manufacturing, and commercialization activities inGreater China and beyond.

Find out more at http://www.cytoviatx.com

About Cellectis Cellectis is a gene editing company, developing first of its kind therapeutic products. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to achieve therapeutic gene editing in hemopoietic stem cells for various genetic disorders. As a clinical-stage biopharmaceutical company with over 21 years of expertise in gene editing, Cellectis is developing life-changing cell therapy product candidates utilizing TALEN, its gene editing technology, andPulseAgile, its pioneering electroporation system in order totreat diseases with unmet medical needs.

As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing lifesaving UCART product candidates for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM)..HEALis a new platform focusing on hemopoietic stem cells to treat blood disorders, immunodeficiencies andlysosomalstorage diseases.

Cellectis headquarters are in Paris, France, with locations in New York City, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS).

For more information, visit http://www.cellectis.com Follow Cellectis on social media: @cellectis, LinkedIn and YouTube.

For further information on Cellectis, please contact:

Media contacts: Margaret Gandolfo, Senior Manager, Communications, +1 (646) 628 0300 Pascalyne Wilson,Director,Communications,+33776991433, media@cellectis.com

Investor relation contact: EricDutang, Chief Financial Officer,+1 (646) 630 1748, investor@cellectis.com

For further information on Cytovia Therapeutics, please contact:

Investor contact: Anna Baran-Djokovic VP, Investor Relations and Capital Markets anna@cytoviatx.com +1 (305) 615 9162

Media contact: Sophie Badr VP, Corporate Affairs sophie.badre@cytoviatx.com +1 (929) 317-1565

Shani Lewis LaVoieHealthScience slewis@lavoiehealthscience.com +1 (609) 516-5761

Forward-looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as at this time, anticipate, believe, expect, on track, plan, scheduled, and will, or the negative of these and similar expressions. These forward-looking statements, which are based on our managements current expectations and assumptions and on information currently available to management, include statements about our research and development projects and priorities, our pre-clinical project development efforts and the timing of our presentation of data. These forward-looking statements are made in light of information currently available to us and are subject to numerous risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development as well as the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. With respect to our cash runway, our operating plans, including product development plans, may change as a result of various factors, including factors currently unknown to us. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2020 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

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Cytovia and Cellectis Expand Their TALEN Gene-Edited iNK Partnership to Enable Broader ... - The Bakersfield Californian

A trial is currently recruiting across the US to investigate the safety of a new anti-PD-1/CD3 antibody for the treatment of relapsed or refractory T-cell lymphoma. It aims to enroll 86 patients.

A trial to investigation a new anti-PD-1/CD3 bispecific antibody, ONO-4685, for the treatment of relapsed or refractory T-cell lymphoma, is currently recruiting across the United States, according to a press release by ONO Pharma USA, Inc.

ONO-4695 binds to human PD-1 and CD3. It is being developed simultaneously as a treatment for autoimmune diseases and hematologic malignancies. PD-1 is expressed in activated T and B cells, along with malignant T-cells in some subtypes of T-cell lymphomas. CD3 is also a component protein of T-cell receptors. Non-clinical data suggests that ONO-4695 may be active against T-cell lymphomas.

In interventional, single-group assignment, open label study (NCT05079282) has an estimated enrollment of 86 participants and an estimated study completion date of July 2026. The primary end points of the study are the incidence, nature, and severity of treatment-emergent adverse events (AEs) and treatment-emergent serious AEs, along with estimated maximum tolerated dose. Secondary end points include plasma concentration of ONO-4685 up to 48 weeks, the plasma concentration of anti-drug antibodies up to 48 weeks, and the antitumor activity of ONO-4685 up to 1 year.

During the study, all patients will receive ONO-4685 monotherapy. Treatment will be administered by intravenous infusion and continued until disease progression or unacceptable toxicity.

In order to participate in the study, patients must be at least 18 years of age or older at the time of screening, have a confirmed diagnosis of one of the following:

Additionally, the patient must have received at least 2 prior systemic therapies, at least 1 measurable lesion if the patient has PTCL, patients with CTCL must have assessable disease, an ECOG performance status of 0-2, a life expectancy of at least 3 months, and adequate bone marrow, renal, and hepatic functions.

Patients with central nervous system involvement, adult T-cell leukemia/lymphoma, prior allogeneic stem cell transplant, prior treatment with an anti-PD-1/anti-PD-L1, a history Mycobacterium tuberculosis infection within 2 years of the first study dose, systemic active infection including HIV, and those who are pregnant or lactating are not eligible to participate.

"We are excited to initiate the phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody with a novel mechanism of action, and hope that ONO-4685 will provide benefit to the patients with relapsed or refractory T-cell lymphoma in the US one day," saidMasahiro Katayama, executive vice president, US/EU and head of clinical development, ONO PharmaUSA, Inc in a press release.

The study is currently recruiting in Alabama, California, Massachusetts, New York, North Carolina, and Texas.

See the rest here:
Study Underway to Evaluate New PD-1/CD3 Antibody in T-cell Lymphoma - Targeted Oncology

She grew in a glass jar as an embryo and was later placed in her mothers womb.

Louise Brown, the worlds first baby conceived outside of the human body, celebrated her 43rd birthday this July 25. I was subjected to more than 100 tests after my birth to ensure I was a normal child, she told THE WEEK.

Louise was a child of perseverance and relentless hope. Her parentsGilbert John Brown, a truck driver, and Lesleydesperately wanted a baby. The couple, who lived in Whitchurch, England, tried to conceive for nine years without success. Lesley had fallopian tube blockages that made natural conception impossible. She had undergone failed operations in the past to clear her blocked tubes and was prepared to put up with anything to have a baby.

On November 10, 1978, the couple underwent a procedure, wherein a mature egg extracted from one of Lesleys ovaries was fused with Johns sperm in a laboratory under the direction of physiologist Sir Robert Geoffrey Edwards and gynaecologist Patrick Christopher Steptoe. Lesley was warned that there was only a one in a million chance of having a baby, but she clung to hope.

The egg was fertilised and divided into two, four and then eight cells. Lesley got pregnant after the eight-celled embryo was implanted in her womb. Being the first woman to have conceived via in vitro fertilisation (IVF) and have a pregnancy that went beyond a few weeks, Lesley attracted a lot of media attention. Edwards and Steptoe found it hard to shield her from the media frenzy. She was hounded by the press so much that Steptoe hid her in his car and drove her to his mothers place in Lincoln. Later, when Lesley was admitted to Oldham hospital for delivery, reporters entered her room posing as housekeeping staff.

Louise Joy Brown, weighing five pounds 12 ounces, was born by C-section at 11.47pm on July 25, 1978. The Joy in her name was a suggestion from the two doctors. Her birth marked a milestone in modern medical science. It was described by TIME as the most awaited birth in perhaps 2,000 years. The baby offered a ray of hope to millions of childless couples across the world. Until then, for women with damaged fallopian tubes, it was impossible to conceive. Edwards won the Nobel Prize in 2010 for the development of IVF therapy, considered one of the most remarkable medical breakthroughs of the 20th century. Around eight million babies have been born in the last four decades through assisted reproduction technologies, including IVF.

Louise realised she was an IVF baby only when she started going to school. Lesley showed her a video footage of her birth. IVF was unheard of in those days and people were curious about her unique birth. She had always been big-bodied and some would ask her how she managed to fit in the test tube.

The Browns were in the spotlight for many years after Louises birth. They were criticised for allowing the doctors to film the birth. Soon after Louises birth, Lesley received a post bag full of letters splattered in red. Once, she received a box from the US that contained a broken test tube and a plastic foetus. Louise defended her mother, saying that letting the doctors film the birth was an act of gratitude for her.

Things were no different for Edwards and Steptoe. They had a hard time breaking the taboo and stereotypes around IVF. The idea of fertilising an egg outside the body has always been controversial. The first such successful experiment was done at Boston in 1944 by Miriam Menkin, essentially a scientist at heart and mind but often relegated to a lab technician or research assistant to the better-known fertility specialist and contraceptive pill co-developer John Rock. The research got derailed with Menkins move to North Carolina, where IVF was considered scandalous, following her husbands job loss. But it was Menkins initial research that eventually led to Louises birth through IVF.

Edwards, Steptoe and nurse Jean Purdy, whose contribution was forgotten till recently, feared criticism from the church and the public and they kept their work under wraps. Only five of the 282 women who underwent IVF could get clinically pregnant and none of them had delivered a live baby. Many embryos died during the process. Unsurprisingly, the medical community refused them support for research. The UK Medical Research Council feared children born through IVF would run a risk of fatal abnormalities. IVF children, Louise said, are no different from normal children. The only difference is the process of conception, she said. It is impossible to distinguish between an IVF baby and other children born naturally.

John and Lesley went for IVF again and had a second childNatalie. The couple wanted a third child, but their attempts failed. Natalie was the 40th child to be born through IVF. She became the first IVF child to conceive naturally, easing concerns that women born through IVF cannot conceive naturally. Natalie now has five children.For the Browns, IVF changed their life in more ways than one. Lesley was Johns second wife; he had two daughters from a previous marriage. John and Lesley, who stayed in an abandoned railway carriage on the first night of their elopement, had a hard life. Homeless, penniless and unemployed, they struggled a lot until John got a job as a bus conductor.

Infertility was an extremely frustrating experience for Lesley. In an interview to Daily Mail later, she said, You feel you are not the same as ordinary wives. You dont feel normal. You feel you are not a real woman. I said to John, Go and find a proper wife.

The couple couldnt afford IVF until 1977, when John won 750, by betting on the outcome of a football match. That helped him pay for the IVF treatment.After Louise was born, the Browns earned money by doing exclusives. Louises birth was reported exclusively by Daily Mail. Associated Newspapers Ltd, the parent company of Daily Mail, secured exclusive rights to the story and pictures reportedly by paying $600,000. Lesley and John stayed positive amid the negativity that was directed at them. They went on speaking assignments around the world as advocates for IVF.

Louise now lives in Oldham with her husband Wesley Mullinder, a nightclub bouncer. Interestingly, Mullinder first met Louise when she was just a few days old. Eight-year-old Mullinder lived across the street from the Browns and was among the crowd gathered to see the extraordinary baby. The duo later met when Louise was 24. Two years later, they were married. They have two boysCameron and Aiden. Cameron is 14 and has just begun with his General Certificate of Secondary Education exams; he will be applying for college in another two years. Aiden turned eight this August.

All her life, Louise received media attention. And now she is consciously using the media glare on her to break the stigma associated with infertility and IVF treatments. Couples suffer through a lot of emotional and psychological stress. I think no couple should be deprived of parenthood, said Louise, who has shared the story of her extraordinary birth and its impact on her life in her memoir My Life As The Worlds First Test Tube Baby. Through my association with ART Fertility Clinics India, I will be working towards the mission of making IVF the wise choice of treatment, enabling couples to realise the dream of parenthood. Another purpose is to assert that all those who need IVF should have access to it.

IVF has come a long way. Scientists now pin their hopes on IVG (in vitro gametogenesis), which could make it possible to produce babies from skin cells. IVG seemed promising when tested in mice. In 2016, a group of researchers in Japan created embryos using skin cells from mice. The embryos wereimplanted, and eight healthy mice were born.

Scientists are now exploring the possibility of making human babies in the lab using skin cells. Imagine a couple wanting to have a baby walking in to a lab to give their skin biopsy samples. The cells from these samples will be transformed into stem cells, which, in turn, will be reprogrammed into sperms and eggs. The process involves creating embryos outside the womb and then transferring them into the womans womb for implantation, as in IVF. IVG holds much promise for people who cannot conceive naturally, especially menopausal women, gay and lesbian couples and men with abnormal sperm function or low sperm production.

Dr Henry T. Greely, author of The End of Sex and the Future of Human Reproduction, said that in future, sex will no longer be a popular means of reproduction for people in developed countries. People will continue to have sex. But those who want to have a baby would prefer to go to a lab, said the Stanford professor of law and genetics. IVG for humans will be a reality within our lifetime, said Greely.

Every woman has the right to have a child, said Louise. Treatment for fertility problems is a right that should be made available to all women, she said. IVF not only creates a child, but a family, she added. Despite her extraordinary birth, Louise lives an ordinary life. She worked in a nursery in her early 20s. Currently, she works for a freight company in Bristol. Her days begin with planning meetings with her team at National Fertility Society; her evenings are dedicated to her family. Home means a lot to Louise, who was a much loved and much longed for child. Her mother had carefully kept everything concerned with her birth, from hospital appointment cards and correspondence to letters from journalists and well-wishers and even a movie script by Carl Foreman, Oscar-winning Hollywood film producer. Louise donated them to the Bristol Archives. Among them is a letter from Edwards to Lesley, dated December 6, 1977, which reads:

Dear Mrs Brown,

Just a short note to let you know that the early results on your blood and urine samples are very encouraging, and indicate that you might be in early pregnancy.

So please take things quietlyno skiing, climbing, or anything too strenuous including Xmas shopping!

If you should wish to get in touch with me for any reason before seeing Mr Steptoe next week, my laboratory number is 0223 65069, and my home number is 0223 54019. Best wishes.

Yours sincerely,

Dr R.G. Edwards

All these mementos were found in Lesleys wardrobe following her death. She died due to complications of a gallbladder infection on June 6, 2012. She never regretted her choices.

Read more here:
What it means to be the worlds first IVF baby - THE WEEK