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Kiromic BioPharma Achieves Milestone with Timely Completion of Expanded cGMP Manufacturing Facility to Support Cell Therapy Oncology Pipeline -…

Posted: July 11, 2022 at 2:38 am

HOUSTON--(BUSINESS WIRE)--Kiromic BioPharma, Inc. (NASDAQ: KRBP) (Kiromic or the Company), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, announces the timely completion of construction on its expanded current good manufacturing practice (cGMP) manufacturing facility in Houston. This significant milestone was accomplished within the timeline established by the Company, specifically June 30, 2022.

The expanded facility located at Kiromics headquarters is one of the conditions required for the Company to begin the activation of its cell therapy clinical trial for the Deltacel product candidate by the end of this year. The completion also addresses a key component in the clinical hold communication the Company received from the U.S. Food and Drug Administration (FDA) in June 2021.

The on-time completion of our cGMP manufacturing facility is one of the conditions necessary to begin the activation of the Deltacel clinical trial by the end of this year, stated Pietro Bersani, Kiromic BioPharmas Chief Executive Officer. The facility supports an expanding product pipeline of cell therapies designed to target solid tumors, furthering our commitment to delivering lifesaving treatments to patients with cancer who have limited therapeutic options. We believe our allogeneic, off-the-shelf manufacturing process will result in shorter lead times and lower costs, thereby increasing the availability of these promising cellular therapies for oncology patients.

The expanded 34,000-square-foot facility includes flexible cellular therapy and viral vector suites, a dedicated cGMP microbiology lab, a dedicated cGMP quality control (QC) lab, a research and development laboratory, and an FDA Code of Federal Regulations (CFR-9) compliant vivarium.

About Kiromic BioPharma

Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) 2.0 platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases. Kiromic is in the process of developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid cancers. From its heritage as a cancer vaccine development company, Kiromic is focused on discovering, developing, and commercializing novel immuno-oncology applications through its robust product pipeline. The pipeline development is leveraged through the Companys proprietary target discovery engine called "DIAMOND." Kiromic's DIAMOND is where data science meets target identification to dramatically compress the years and hundreds of millions of dollars required to develop a live drug. The Company maintains offices in Houston, Texas. To learn more, visit http://www.kiromic.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Kiromic makes such forward-looking statements pursuant to the safe harbor provisions of the United States Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as: will, potential, could, can, believe, intends, continue, plans, expects, anticipates, estimates, may, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding: Kiromics current and anticipated IND applications including statements regarding the scope of and timing for submission of an IND application; the Deltacel product platform; the sponsored research agreement and the data that will be generated as a result of such collaboration; the timing for submitting and activating Kiromics IND applications; the benefits of utilizing non-genetically engineered Gamma Delta T cells as our first in-human study; Kiromics ability to achieve its objectives; and the timing for the initiation and successful completion of Kiromics clinical trials of its product candidates. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in our Annual Report on Form 10-K for the year ended December 31, 2021, and as detailed from time to time in our SEC filings. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Such forward-looking statements relate only to events as of the date of this press release. We undertake no obligation to update any forward-looking statements except to the extent required by law.

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DNA and gene editing are the real stars of the new Jurassic Park movie – Genetic Literacy Project

Posted: July 11, 2022 at 2:38 am

If a new Planet of the Apes or Jurassic Park film comes out, Im going to go see it. The latest, Jurassic World: Dominion, didnt disappoint.A plague of locusts

The science is mostly accurate, the bioethics message obvious, and the plot adheres to Isaac Asimovs change one thing rule for science fiction. In the world of Jurassic Park, that lone variable is time. We just have to accept that a titanosaur like Argentinosaurus somehow grew and developed from a lab-nurtured baby to a 130-foot-tall and 110-ton adult in a few years.

The official summary from IMDb for the new film is vague and continues the impossibly-rapid-growth theme:

Four years after the destruction of Isla Nublar, dinosaurs now liveand huntalongside humans all over the world. This fragile balance will reshape the future and determine, once and for all, whether human beings are to remain the apex predators on a planet they now share with historys most fearsome creatures in a new Era.

Four years? Animals radiating around the world? Even rats or rabbits couldnt do that. And the film is actually more about insects.

Evil company Synbio has let loose hordes of genetically modified locusts, each the size of a shoebox. They eat only crops that havent been grown with the companys insecticide. (Old story, the first GMO corn was grown in 1996.) The rapidly-reproducing, gargantuan locusts are expected to decimate the nations crops by summers end.

The upper floors at Synbio appear innocent: a clearinghouse to rehab the poor reptiles roaming the planet after they burst free in the last movie. The beasts are then sent to a Wildlife Relocation Center in Pennsylvania or to a facility in the Dolomite Mountains of Italy for some R&R. Synbio bought the company behind Jurassic Park back in the 90s, and it is now focusing on saving 20 key species.

But there are other parts to the company.

The Habitat and Development Laboratory contains untouched genomes of rare species. Underground lies Synbios top secret project, hexapod. Six legs.

The company is conveniently near amber deposits that provided the initial dino DNA back in the 1990s in preserved mosquitoes, and this time around, the locust genetic material. The amber mine looks a lot like Howe Caverns, near where I live in upstate New York.

Of course other folks have dinos too. Sawridge Cattle Company in western Nevada, for example, is now an illegal breeding facility. Cute baby triceratopses are stuffed into cages like the ones at county fairs that house pigs.

The locusts and dinosaurs are the backdrop to the human drama that centers around 14-year-old Maisie Lockwood (Isabella Sermon), granddaughter of Sir Benjamin Lockwood. He was the business partner of John Hammond, both responsible for the modern-day dinos in the first place.

Maisie, it turns out, is a clone. Her mother, Charlotte (Elva Trill), wanted to have a kid, so why not just clone herself? The 23 human chromosome pairs on her computer screen announce that she is a geneticist, although Im a geneticist too and I never feel the need to remind myself of the number, which isnt useful for anything.

Young Maisie is precocious and gorgeous and for unexplained reasons, has an English accent. Owen Grady (Chris Pratt) and Claire Dearing (Bryce Dallas Howard), from the last movie, adopt her and they live in the woods to protect her from kidnappers.

A few dinosaurs live near their house, and Maisie befriends an adorable mom and her baby, Blue and Beta. They arose from dino DNA mixed with monitor lizard DNA, like the frog DNA patched into the genomes of the original Jurassic Park dinos. We need the little raptor to understand you. They are genetically identical, like you and Charlotte. Charlotte, like Blue, was able to have a child all by herself, sneers a kidnapper, for Maisie, too, arose without the contribution of a sperm.

But why would anyone want to kidnap Maisie? Why is she the most valuable IP on the planet?

When Maisie was a toddler, her mother Charlotte, much to her surprise despite the chromosomes on her screen, suddenly sickened from an unnamed, undiagnosed genetic disease, even though young-adult-onset of a genetic disease is rare. Oops! She cloned a child with a mystery mutation!

Not to worry. Charlotte whipped up some viral DNA to deliver working genes, something thats been done in gene therapy since the first experiments, in 1990, coincidentally when Michael Crichton published Jurassic Park. Back then, we could just add genes in gene therapy. But now, thanks to gene editing techniques like CRISPR, we can also remove the bad genes.

Presumably such a gene swap is what Charlotte did to beget Maisie. Whatever she did, we know that the important part is that she made the change in every single cell of her toddlers body, which is difficult to envision. Several characters say every single cell so we know it is true, although with current technology, that is not possible. Gene therapy on a person targets specific cell types that are involved in the disease.

However Charlotte jettisoned the bad genes out of her kid, Maisie is here, and she holds the secret to how pathologist Henry Wu (BD Wong from Law and Order) can rid the world of the locusts: apply the same technology that Charlotte used to knit a genetic change into all the trillions of her daughters cells.

She changed every cell in your body, Wu reminds Maisie. If I can figure out how, I can change the entire swarm before its too late. Your DNA could change the world! If I could, I could fix a terrible mistake that I made, he laments, referring to the bioengineering of the giant locusts.

A large-scale change that eradicates a species, even if locally, is indeed possible with a technology called a gene drive. I explain it here. Its not a very good idea.

The problem of the locusts is so profound that the old characters from the original Jurassic Park, circa 1993, come aboard. They re-enact some of the old bantering and flirting, nearly verbatim.

Laura Derns Ellie Sattler gee-whizzes and eye-bulges. Shes the paleobotanist who stuck her hands in dino doo in the inaugural film. She helpfully identifies the locusts as a species that died out during the Cretaceous period (145 to 66 million years ago).

Grumpy paleontologist Alan Grant (Sam Neill) is still grumpy, while pontificating mathematician Ian Malcolm (Jeff Goldblum, also of The Fly fame) still is plagued by clichs: ethics of genetic power, we must trust in humanity, unforeseen consequences, and the nonsensical we must transform human consciousness. He works for the evil company or so it seems. Synbios work, he spouts, will cure autoimmune disease, cancer, and Alzheimers.

Ian invites Ellie and Alan to visit Synbio. Upon arrival, Ian slips her a key to the locust lab.

Theyve all aged remarkably well, trim and with great hair and skin. This contradicts the change one thing mantra of rapidly-developing dinosaurs; non-aging humans.

Several boring chase scenes ensue, the one of barbecuing locusts the most intriguing. The main characters spend about 45 minutes running around the Synbio facility to steal a sample of DNA. It is unclear exactly why theyre doing this, because they can easily get DNA from Maisie, and theyre surrounded by the insects, presumably pooping DNA all over the place.

As the movie drags on, more chase scenes happen, in response to various asset containment breaches. The most exciting is a duel between two ferocious dinos: two apex predators in one place! Ellie chants. Oh my!

In yet another scene, as a horrified Claire looks on in a forest, a ginormous dino slurps up deer like my husband eats Trader Joes potato chips.

Our friends, after many near-death experiences, save the day. The surviving humans flee as dinos burn. At an unnamed later time, Dr. Wu waves a magic wand and the locust problem is solved.

The plot holds together loosely. What kept me awake, once Id gotten over the novelty of the dinosaurs (yes, they have feathers), were the scenes borrowed from other films and TV shows.

Owen spies a pterodactyl on the wing of a plane that resembles Star Wars Millennium_Falcon, echoing the Nightmare at 20,000 Feet Twilight Zone episode in which William Shatner (aka Captain Kirk) spies a monster on the wing of a plane.

Why did it have to be snakes? uttered Indiana Jones after plunging into a serpent-filled chasm. Nobody said thered be bugs! is the new version.

Claire bails out of the Millennium Falcon and evokes the winged monkeys of the Wizard of Oz. Later on, shes spies small dinos pop up from the shrubbery like the munchkins along the yellowbrick road.

Claire and Owen sneak into the locust lab wearing white suits that look EXACTLY like the deployed sperm in Woody Allens Everything You Always Wanted to Know About Sex.

For no clear reason, theres a re-enactment of the cantina scene from Star Wars, complete with locusts turning on a barbecue spit, gambling, and drinking.

Despite the absurdity of populating a planet with full-grown, bellowing dinosaurs in a fraction of time, Ill go back for the next installment of Jurassic World. Meanwhile, Id like to know how Ellie, Alan, and Ian aged so well.

Ricki Lewis has a PhD in genetics and is a science writer and author of several human genetics books.She is an adjunct professor for the Alden March Bioethics Institute at Albany Medical College.Follow her at herwebsiteor Twitter@rickilewis

A version of this article was originally posted atPLOSand has been reposted here with permission. PLOS can be found on Twitter@PLOS

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Taysha Gene Therapies to Release First Quarter 2022 Financial Results and Host Conference Call and Webcast on May 16 – GuruFocus.com

Posted: July 11, 2022 at 2:38 am

DALLAS, May 11, 2022 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. ( TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today announced that it will report its financial results for the first quarter ended March 31, 2022, and host a corporate update conference call and webcast on Monday, May 16, 2022, at 8:00 AM Eastern Time.

About Taysha Gene Therapies

Taysha Gene Therapies ( TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.

Company Contact:Kimberly Lee, D.O. Chief Corporate Affairs OfficerTaysha Gene Therapies[emailprotected]

Media Contact:Carolyn HawleyCanale Communications[emailprotected]

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Engineering Graduate Fellows Get Hands-on Experience with National Industry Leaders – UCF

Posted: July 11, 2022 at 2:36 am

Seven University of Central Florida graduate students are currently interning at Adobe and 3M, among other leading employers thanks to fellowships supported by the National Graduate Degrees for Minorities in Engineering Fellowship (GEM) program.

The GEM program began in 1976. The public-private partnership aims to connect students from underrepresented groups with the nations top employers and universities. Those selected receive a $16,000 fellowship from the GEM Consortium, a paid summer internship, and a tuition remission for a masters or doctoral program of their choice. The national program is highly competitive and enables students to be placed in coveted internships with some of the nations industry leaders in STEM.

UCF has been a partner university for more than 20 years. The GEM program is one of several supporting students of color at UCF, a Hispanic Serving Institution.

This years UCF GEM Fellows are:

Novia Berriel 21MS

Currently a researcher in associate professor of materials science Parag Banerjees lab, Novia Berriel will continue her education as a doctoral fellow in materials science. She originally came to UCF because of the so-called two-body problem the need for two professional spouses to find suitable placements in the same area but has since fallen in love with everything the university has to offer.

UCF is at the cutting edge of everything, she says. And being a Hispanic woman, I appreciate that its an HSI.

Berriel earned her masters in physics at UCF in 2021. Since she began the degree in 2018, she has been working to explore atomic layer deposition of thin films. In this capacity, shes been able to engage with different disciplines by producing the films needed for a variety of devices.

The opportunity to be interdisciplinary in your everyday life is one of her favorite aspects of the materials science department at UCF.

You can collaboratively interface with so many other labs, Berriel says. I work in Research Building I, which houses faculty and labs from many different departments. So, Ive been able to meet experts in different disciplines by just walking around.

As a GEM fellow and intern for Lam Research, she hopes to build expertise in semiconductor development and solar cells, while making the most of the chance to research freely, meet other Fellows and embrace interdisciplinary collaboration.

Jeffrey Chan-Santiago

Drawn to UCFs state-of-the-art research at the intersection of computer vision, machine learning and robotics, Jeffrey Chan-Santiago knew it would be the best place to earn his doctorate in computer science.

He already has experience applying self-supervised models to monitor and identify honeybees in their natural habitat, modify architectural plans and more through work he conducts at the University of Puerto Rico, Ro Piedras. He earned a bachelors degree in computer science from the university and is currently completing his masters degree in applied mathematics.

He is also an intern at Raytheon for the summer. There and at UCF, he hopes to enable robots to learn more efficiently and safely.

He says he is grateful to be at one of the first steps of a lifelong career in research, and he plans to become a professor, ideally in Puerto Rico, and help motivate students toward research careers in STEM.

Joseph Green

As a GEM fellow at UCF and an intern for Adobe, Joseph Green hopes to broaden his every horizon.

He received his bachelors degree in computer science in 2020 at Auburn University, and says he is eager to make the transition to highly populated Orlando, which has attractions like Walt Disney World.

Green credits his participation in the GEM Fellowship program to encouragement he received as part of a learning community at Auburn. He says he looks forward to joining similarly supportive communities at UCF. This will be his first time living in an area he doesnt know, but Green says he already knows he will have a great time experiencing a new schools culture.

In the process, he says he will be able to see all the variety his field has to offer.

During his masters program in computer science, he plans to make the most of the opportunity to pursue machine learning, complex networks and other inspiring topics.

Dania Jean-Baptiste

Earning her bachelors degree with honors in computer information systems from Bethune-Cookman University in 2021 made Dania Jean-Baptiste realize how much she enjoyed her field and how much she had left to learn.

To ensure her work would remain at the cutting edge of security standards, Baptiste decided to pursue a masters degree in cybersecurity and privacy. She initially enrolled at Florida A&M University; however, she decided to transfer to another university. Although the transition was difficult, she says having faith helped her continue her path.

So, she applied and was admitted to be a GEM Fellow at UCF. Her fellowship is sponsored by Intel. And this summer, Baptiste is participating in Tech Forward a Salesforce training program that prepares participants from underrepresented groups to earn their certification in network administration.

Baptiste says she looks forward to enriching experiences in research. Her ultimate goal is to learn as much as she can about data analytics, artificial intelligence and cloud computing. Then, she will be able to put her skills to use while giving back to her community.

Andrea Molina Moreno 22 After building a foundation in the different areas of STEM, Andrea Molina Moreno decided to focus on materials engineering.

She says that it has a uniquely broad scope. You can work with anything you choose, since almost everything is material.

Moreno came upon this decision in the midst of several transitions: immigrating from Caracas, Venezuela, transferring from Simn Bolvar University, and graduating among UCFs first cohort of bachelors materials science students.

With the GEM fellowship, she will pursue a doctoral degree in materials science. This summer, she is gaining experience in industry by interning at 3M in Minneapolis. As she continues her education, Moreno most looks forward to serving as a role model for fellow Hispanic female engineers.

What has motivated her so far is the desire to gather as much knowledge as she possibly can. She shares that Ive been studying for so much of my life, and its what I really enjoy doing learning more and more.

Jason Ortiz

The COVID-19 pandemic gave Jason Ortiz an opportunity to pause and think back to some of his original passions.

In 2021, he had already spent three years working as a software engineer at Microsoft in Seattle, where he enjoyed the opportunity to tackle exciting problems in cloud-computing. Still, he had always hoped to further explore 3D applications. Extended reality (XR) encompassing the spectrum of virtual, mixed and augmented reality applications particularly stood out to him.

He says he realized that the fields potential is outstanding. It can address a lot of problems related to isolation, by helping people work in novel ways while still feeling a sense of togetherness. So, he did a bit of research in his downtime.

Thats when Ortiz discovered the pioneering work of UCF Engineering Professor Carolina Cruz-Neira. Even better, Cruz-Neira was teaching in Orlando, his hometown. The GEM Fellowship offered a way to return for his doctorate.

He jumped at the chance. Currently an intern at Argonne National Laboratory, Ortiz will begin as a student at UCF in the fall. He most looks forward to conducting innovative research on collaborative XR and building the teaching skills he began developing as an undergraduate teaching assistant. He is also eager to be the first in his family with a doctorate and hopes to encourage fellow Puerto Ricans to pursue higher education.

Kiaria Tucker

After years of watching crime shows and pointing out technicians as the real heroes, Kiaria Tucker found it easy to decide on a career path.

She remembers that the detectives never actually held my interest. The technicians were the ones who could say This is what happened. This is what the evidence shows. Its thanks to the technicians that they had the evidence they needed to do anything.

Forensic science offered the opportunity for excitement and a tangible impact. So, Tucker received her bachelors degree in chemistry with a forensic concentration from Talladega College. While there, she participated in the McNair Scholars Program, where a mentor encouraged her to apply to the GEM fellowship.

Since her acceptance, Tucker has explored microbiological chemistry research as an intern for Oak Ridge National Laboratory in Knoxville, Tennessee. This fall, she will begin as a thesis-seeking doctoral student in chemistry at UCF. Tucker says she looks forward to earning the skills and certifications that will make her a valuable member of a forensic team. She says from everything shes seen so far, the field still never fails to excite her.

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Stem Cell Hair Transplant: What Is It and When Will It Be Available?

Posted: July 11, 2022 at 2:33 am

A stem cell hair transplant is similar to a traditional hair transplant. But rather than removing a large number of hairs to transplant to the area of hair loss, a stem cell hair transplant removes a small skin sample from which hair follicles are harvested.

The follicles are then replicated in a lab and implanted back into the scalp in the areas of hair loss. This allows hair to grow where the follicles were taken from, as well as where theyre transplanted.

Stem cell hair transplants exist only in theory at the moment. Research is ongoing. Its estimated that stem cell hair transplants may be available by 2020.

Stem cells are cells that have the potential to develop into different types of cells found in the body. Theyre unspecialized cells that are unable to do specific things in the body.

However, theyre able to divide and renew themselves to either stay stem cells or become other types of cells. They help repair certain tissues in the body by dividing and replacing damaged tissues.

A stem cell hair transplant was successfully performed by Italian researchers in 2017.

The procedure begins with a punch biopsy to extract stem cells from the person. The punch biopsy is performed using an instrument with a circular blade thats rotated into the skin to remove a cylindrical sample of tissue.

The stem cells are then separated from the tissue in a special machine called a centrifuge. It leaves a cell suspension thats then injected back into the scalp in the areas of hair loss.

There are several different research teams working on stem cell hair loss treatments. While the procedures may vary slightly, theyre all based on growing new hair follicles in a lab using a small skin sample from the patient.

Currently, there are some clinics offering a version of stem cell hair transplants to the public. These arent approved by the U.S. Food and Drug Administration (FDA). Theyre considered investigational.

In 2017, the FDA released a warning about stem cell therapies. The warning advises anyone considering stem cell therapies to choose those that are either approved by the FDA or being studied under an Investigational New Drug Application (IND). The FDA authorizes INDs.

These procedures are performed in-office on an outpatient basis. They entail removing fat cells from the persons abdomen or hip using a liposuction procedure under local anesthesia.

A special process is used to remove the stem cells from the fat so that they can be injected into the scalp. This procedure takes approximately 3 hours.

The clinics that currently offer this procedure cant provide a guarantee for the outcome of the procedure. The results, if any, can vary from person to person. It may require several treatments over many months to see results.

Some research has found stem cell hair transplants can be effective in treating different hair loss conditions, including:

Some pain following the procedure is expected. It should subside within a week.

No recovery time is required, though excessive exercise should be avoided for a week. Some scarring can be expected where the fat has been removed.

You wont be able to drive yourself home following the procedure because of the effects of the local anesthesia.

Theres very little information available about the possible side effects of stem cell hair transplants. As with any medical procedure, theres always the risk of bleeding or infection at the site of the sample and the injection. Scarring is also possible.

Though complications from a punch biopsy are rare, theres a small risk of damage to the nerves or arteries beneath the site. Liposuction can also cause the same side effects and complications.

The research available on the success rate of stem cell hair transplants is very promising. The results of the Italian study showed a 29 percent increase in hair density 23 weeks after the last treatment.

The clinics that currently offer stem cell hair therapies not approved by the FDA dont make any guarantees in regard to results or success rates.

The cost of stem cell hair transplants hasnt been determined since theyre still in the research stages.

Some of the investigational stem cell hair replacement therapies being offered by various clinics range from approximately $3,000 to $10,000. Final cost depends on the type and extent of the hair loss being treated.

The stem cell hair transplant treatments being researched are expected to be available to the public by 2020. Stem cell hair transplants offer options to people who arent candidates for the hair loss treatments currently available.

While some clinics are offering stem cell hair replacement therapies, these are considered investigational and havent been approved by the FDA.

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Stem cell treatments and regulation – a quick guide for consumers

Posted: July 11, 2022 at 2:33 am

What are stem cells?

Our bodies are made up of about 200 different types of cells, such as muscle cells, skin cells and nerve cells. Each cell type performs a specialised function. Stem cells are cells that are not specialised. Their role is to replace specialised cells that have been lost through injury, diseases, or the normal course of events.

Medical research into stem cells is still at the very early stages. Our understanding of the risks associated with stem cell treatment is limited. Further research is required to create safe and effective treatments.

Are stem cell treatments safe and effective?

In Australia, the only proven safe and effective stem cell treatment is haematopoietic stem cell transplantation (using stem cells from umbilical cord blood or bone marrow) for the treatment of disorders of the blood and immune system such as leukaemia.

Currently, no other stem cell treatment has been demonstrated to be safe and effective. However, some clinics located both in Australia and overseas offer unproven stem cell treatments.

Any unproven stem cell treatment may be unsafe, posing serious risks to your health. The risks include infection, allergic reactions or the development of cancer; complications that can be fatal.

What stem cell treatments are approved by the TGA?

The only established stem cell treatment approved in Australia is haematopoietic stem cell (HPC) transplantation (using stem cells from umbilical cord blood or bone marrow), which is standard practice for the treatment of disorders of the blood and immune system such as leukaemia. The use of fresh bone marrow-derived HPC is standard practice and is exempt from oversight by TGA. Cord-blood derived HPC is usually stored frozen prior to use, so involves some processing, and is approved by TGA.

What are the risks of undergoing unproven stem cell treatments?

An unproven stem cell treatment may also pose serious, potentially fatal, risks to your health including infection, allergic reactions, rejection of the cells by your immune system and the development of cancer.

Unproven stem cell treatments may cause financial hardship, including treatment and ongoing follow-up costs, as well as the cost of emergency medical care in the event that something goes wrong. If you undergo treatment outside Australia, there are additional costs associated with travel.

Importantly, undergoing an unproven stem cell treatment may interfere with proven and potentially beneficial therapies recommended by your general practitioner or specialist. It can also disqualify you from participation in a registered clinical trial.

Does the TGA regulate stem cell treatments?

In Australia, the Therapeutic Goods Administration (TGA) is responsible for the regulation of products for therapeutic use including human cells and tissues (termed 'biologicals'). This includes human stem cell treatments.

However, the TGA does not regulate medical practice. Some products that would otherwise be considered biologicals are excluded from TGA regulation (through the Therapeutic Goods (Excluded Goods) Determination 2018). Under this provision stem cell treatments may not be subject to regulation by TGA if they meet all of the following criteria:

Where one or more criteria are not met, including advertising to consumers, regulation by TGA will apply.

Are there any approved facilities for storing stem cells in Australia?

Cord blood can be stored in Australia. There are approved facilities for storing cord blood stem cells (collected from a newborn's umbilical cord). There are currently no TGA approved facilities for the storage of other stem cells in Australia.

Does the TGA regulate dental pulp stem cells?

Stem cells derived from sources such as dental pulp are subject to the same regulatory requirements as all other human cell and tissue products for therapeutic use.

However, the use of these stem cells to produce a product that could be of therapeutic use is only in the research and development stage. It is possible that in coming years these stem cells will be used in products for clinical trials, but products suitable for full marketing approval by the TGA are still some time away.

What are autologous stem cells?

Autologous cells are those that are removed from, and applied to, the same person, so the donor and recipient are the same.

Is it safe to use autologous stem cells?

Autologous cells are those that are removed from and applied to the same person. These cells may be treated, processed or purified after removal. As the cells come from the same person, there is a lower chance of reaction and rejection of the cells by the patient's immune system.

However, an unproven autologous stem cell treatment may be unsafe, posing serious risks to your health. The risks include infection and growth of specialised tissue in the wrong place (ectopic tissue formation).

Unproven stem cell treatments may also involve significant financial costs, including treatment and follow-up costs, as well as the cost of emergency medical care in the event that something goes wrong. Undergoing an unproven stem cell treatment may interfere with proven and potentially beneficial therapies or treatment plans recommended by your general practitioner or specialist. It can also disqualify you from participation in a registered clinical trial.

Can I use Cord Blood stem cells from my own pregnancy for my own treatment?

The collection and use of cord blood stem cells for a specific patient is known as directed donation. On rare occasions, a hospital will collect and store a baby's cord blood for a family member who has a medical condition that can be treated with cord blood transplantation. This requires a treating doctor's approval.

Should I use a natural therapy that claims to increase stem cells that is not approved by the TGA or available via the Special Access Scheme?

The TGA ensures that where specific therapeutic claims are made about a product or therapy then these are supported and the product is safe. For natural therapies that do not have oversight by TGA there is no guarantee of safety or effective use.

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Using Particles That Are Smaller Than the Head of a Pin to Treat Cancer – Yale School of Medicine

Posted: July 11, 2022 at 2:31 am

Patients with high-grade ovarian cancer and uterine serous cancer (USC) often respond well to surgery and chemotherapy. At first.

But these can be highly aggressive tumors that often spread into the space within the abdomen known as the peritoneal cavity. According to a recent study, one rare but aggressive type of uterine cancer is propelling an increase in deaths from the disease in the United States, particularly among Black women.

Moreover, resistance to chemotherapy often develops, and the disease recurs. This results in ovarian cancer causing more deaths than any other cancer of the female reproductive system.

For one possible treatment, clinical trials demonstrated the effectiveness of injecting a drug known as epothilone B (EB) into the abdominal cavity, targeting tumor cells that have grown resistant to standard chemotherapy medications. However, the drugs high toxicity when delivered this way causes severe side effects, preventing further use.

Now, thanks in part to research begun more than a decade ago with funding from Womens Health Research at Yale, our colleagues are closing in on a way to deploy effective cancer-fighting medication safely with the help of ultra-tiny non-toxic biodegradable objects known as nanoparticles. Developed by Dr. W. Mark Saltzman, the Goizueta Foundation Professor of Biomedical and Chemical Engineering, these nanoparticles have organic chemicals on their surface that allow them to stick to cells in the abdominal cavity so they are not cleared from the area before they can do their job.

With bioadhesive nanoparticles, we can safely entrap a drug and deliver it so it slowly releases in a high concentration, directly to our target, over a long time, Saltzman said. By localizing the delivery of the drug, we are decreasing toxicity and increasing effectiveness.

With data funded through WHRYs grant, Drs. Saltzman and Alessandro Santin, professor of obstetrics, gynecology, and reproductive sciences, secured funding from the National Institutes of Health to demonstrate the safety and efficacy of this technique in a model system, publishing their results in 2016.

Saltzman then partnered with Dr. Michael Girardi, Evans Professor of Dermatology, to develop a non-surgical treatment for skin cancer using injections of nanoparticles carrying a chemotherapy agent. In a paper published last year, they demonstrated the capacity for this method to bind to the tumors and kill a significant number of cancer cells. In addition, the treatment involves triggering an immune response to rid the body of cancer cell waste and respond against any remaining cancer cells.

Drs. Saltzman and Girardi founded a company called Stradefy Biosciences, which has licensed patents to this technology from Yale, while continuing to develop these techniques for clinical use.Dr. Nita Ahuja, William H. Carmalt Professor of Surgery and chair of surgery, serves as an advisor for abdominal cancer applications.

We are thrilled that the work we sponsored many years ago continues to produce such varied applications for serious health concerns, said WHRY Director Carolyn M. Mazure, PhD. This is the model for how investing in Yales most innovative and collaborative individuals can produce steady progress that will improve and even save lives.

Dr. Saltzman also used a WHRY grant to create a vaginal ring that provides contraception while protecting against sexually transmitted infections. Yale has filed a patent application on this unique ring design, and Saltzman continues to seek funding to further develop the product and possibly adapt it to treat endometriosis.

The type of funding WHRY provides is critical for the innovation-based work I do, Saltzman said. I could say, We are going to make these particles with this unique property. But to get substantial buy-in from a company or the NIH, you need to have the data to demonstrate that this works. Early funding, particularly for collaborative projects with unproven technologies, is critical.

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Stem Cell Assays Market Report 2022-2027: Increasing Awareness About Therapeutic Potency of Stem Cells Driving Growth – ResearchAndMarkets.com -…

Posted: July 11, 2022 at 2:31 am

DUBLIN--(BUSINESS WIRE)--The "Stem Cell Assays Market by Type (Viability, Proliferation, Differentiation, Apoptosis), Cell Type (Mesenchymal, iPSCs, HSCs, hESCs), Product & Service (Instrument), Application (Regenerative Medicine, Clinical Research), End User - Global Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.

The stem cell assay market is projected to reach USD 4.5 Billion by 2027 from USD 1.9 Billion in 2022, at a CAGR of 17.7% during the forecast period.

The growth of the market is projected to be driven by collaborations and agreements among market players for stem cell assay products & services, the launch of new stem cell analysis systems such as flow cytometers, and increase in R&D expenditure by biopharmaceutical and biotechnology companies.

The viability/cytotoxicity assays accounted for the largest share of the type segment in the stem cell assays market in 2021

Cell viability assays help to determine the number of live and dead cells in a culture medium. The viability/cytotoxicity assays include various types such as tetrazolium reduction assays, resazurin cell viability assays, calcein-AM cell viability assays, and other viability/cytotoxicity assays. The cell viability/cytotoxicity market is likely to be driven by rising R&D spending on stem cell research, an increase in demand for stem cell assays in drug discovery, and development of new stem cell therapies..

The adult stem cells segment accounted for the largest share of the cell type segment in the stem cell assays market in 2021.

Adult stem cells account for the largest share of the stem cell assay market. The adult stem cells include mesenchymal stem cells, induced pluripotent stem cells, hematopoietic stem cells, umbilical cord stem cells, and neural stem cells. The growth of the adult stems cells segment is driven by the increasing usage of adult stem cells in regenerative medicine and the development of advanced therapies.

Asia Pacific: The fastest-growing region in the stem cell assays market

The Asia Pacific is estimated to be the fastest-growing segment of the market, owing to the rising prevalence of cancer & other diseases, increasing R&D spending on biopharmaceutical projects, and focus on developing stem cell-based therapies. In this region, China and Japan are the largest markets.

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights

4.1 Stem Cell Assays Market Overview

4.2 North America: Stem Cell Assays Market, by Product & Service and Country (2021)

4.3 Stem Cell Assays Market Share, by Type, 2022 Vs. 2027

4.4 Stem Cell Assays Market Share, by Application, 2021

4.5 Stem Cell Assays Market: Geographic Growth Opportunities

5 Market Overview

5.1 Introduction

5.2 Market Dynamics

5.2.1 Drivers

5.2.1.1 Increasing Awareness About Therapeutic Potency of Stem Cells

5.2.1.2 Increasing Funding for Stem Cell Research

5.2.1.3 Rising Demand for Cell-Based Assays in Drug Discovery

5.2.1.4 Collaborations and Agreements Among Market Players for Stem Cell Assay Products & Services

5.2.1.5 Rising Incidence of Cancer

5.2.2 Restraints

5.2.2.1 Issues in Embryonic Stem Cell Research

5.2.2.2 High Cost of Stem Cell Analysis Instruments

5.2.3 Opportunities

5.2.3.1 Emerging Economies

5.2.3.2 Government Initiatives to Boost Stem Cell Research

5.2.4 Challenges

5.2.4.1 Lack of Infrastructure for Stem Cell Research in Emerging Economies

5.2.4.2 Dearth of Trained and Skilled Professionals

5.3 Ranges/Scenarios

5.4 Impact of COVID-19 on Stem Cell Assays Market

5.5 Trends/Disruptions Impacting Customers' Business

5.6 Pricing Analysis

5.6.1 Average Selling Prices of Products Offered by Key Players

5.6.2 Average Selling Price Trend

5.7 Technology Analysis

6 Stem Cell Assays Market, by Type

6.1 Introduction

6.2 Viability/Cytotoxicity Assays

6.3 Isolation & Purification Assays

6.4 Cell Identification Assays

6.5 Proliferation Assays

6.6 Differentiation Assays

6.7 Function Assays

6.8 Apoptosis Assays

7 Stem Cell Assays Market, by Cell Type

7.1 Introduction

7.2 Adult Stem Cells

7.3 Human Embryonic Stem Cells

8 Stem Cell Assays Market, by Product & Service

8.1 Introduction

8.2 Instruments

8.3 Kits

8.4 Services

9 Stem Cell Assays Market, by Application

9.1 Introduction

9.2 Regenerative Medicine & Therapy Development

9.3 Drug Discovery & Development

9.4 Clinical Research

10 Stem Cell Assays Market, by End-User

11 Stem Cell Assays Market, by Region

12 Competitive Landscape

13 Company Profiles

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/hvgp4o

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Sickle cell disease could be treated with common plant, study finds – The Telegraph

Posted: July 11, 2022 at 2:31 am

A common plant from west Africa works as a treatment for sickle cell disease, new research has found.

Scientists at Aberystwyth University isolated a chemical in the Alchornea cordifolia plant, also known as the Christmas Bush, which could help relieve the symptoms of the life-threatening and painful disease suffered by 15,000 people in the UK.

In sufferers of sickle cell anaemia, red blood cells change from their usual soft disc shape to a curved "sickle" shape and also become sticky and hard, which means they don't move properly around the body.

Blood is blocked from flowing, particularly to joints, the chest and abdomen, leading to severe pain, swelling of hands and feet, delayed growth and problems with eyesight, among other symptoms. It can lead to stillbirth and is also fatal in some cases.

A genetic disease, it is more common among people of African, Mediterranean and Middle Eastern descent, with over 20m people around the world affected.

In Nigeria around 150,000 children are born with sickle cell anaemia each year. Half of them are likely to die before their 10th birthday.

Juice from the plant, which grows widely across the tropical regions of Africa, has been used in a "blood tonic" as a traditional remedy for generations, but it has never been scientifically proven to work until now.

Dr Olayemi Adeniyi, a researcher at the university who suffers from the condition herself, interviewed traditional healers from south western Nigeria, who said the plant had been used for years as a treatment.

Leaves are crushed manually or blended, and can also be brewed into a tea.

Dr Adeniyi said the research had shown that quercitrin, the active ingredient in the plant, could both prevent and reverse the "sickling" caused by the disease.

She said: "Until now there has been no scientific proof of the plants effectiveness.

The research is particularly important because so many people affected by sickle cell disease live below the poverty line and have no access to medicine. The plant grows in bushes and is relatively easy to grow on fertile land - all you need are seeds.

Its crucial that people in the countries affected, Africa in particular, hear that this plants benefits have now been scientifically proven. Our findings show that this is a treatment that has firm scientific foundations, not just psychological ones.

Existing treatments are expensive, and some involve blood transfusions. It can only be cured with a stem cell or bone marrow transplant, but this is rarely done because of the risks involved.

The finding "could inform efforts directed to the development of an anti-sickling drug", the paper concluded.

The study formed part of an Aberystwyth University project looking at the scientific effectiveness of traditional and herbal remedies, which has also focused on developing new antibiotics to counter the growing problem of antimicrobial resistance.

Professor Luis Mur, who led the research, said: "We're running out of drug leads. There is a recognition, especially with diseases, that they are evolving, and they're evolving through misuse of antimicrobials for example, and so we need to look at new sources.

"So let's go back to where traditional practices have actually given a hint that this particular plant or fungus has some efficacy."

The results were published in the Journal of Clinical Medicine.

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Sickle cell disease could be treated with common plant, study finds - The Telegraph

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Unexpected link between most common cancer drivers may yield more effective drugs – University of Wisconsin-Madison

Posted: July 11, 2022 at 2:31 am

From left, Vincent Cryns, Mo Chen and Richard A. Anderson. Photo by Tianmu Wen

Two of the most common genetic changes that cause cells to become cancerous, which were previously thought to be separate and regulated by different cellular signals, are working in concert, according to new research from the University of WisconsinMadison.

To date, researchers have focused on finding drugs that block one or the other to treat cancer. Understanding their cooperative effects may lead to more effective treatments.

Cells muster a protein, called p53, which acts inside the cell nucleus to respond to stress, but mutations of the gene that produces p53 are the most frequent genetic abnormalities in cancer. Mutations activating a cellular pathway called PI3K/Akt, located on the surface of cells, are also often implicated in runaway cell growth in cancer.

Outlined in green, this nucleus of a cancerous cell contains DNA in blue and red blobs marking the cells p53 protein binding with parts of the Akt cellular signaling pathway, a partnership that will prevent the cancerous cell from dying as it should and instead prolong its life and lead it to divide into more cancer cells. Image by Mo Chen

Cellular signaling pathways allow cells to accomplish important communications tasks that maintain healthy cell functions. The process is a bit like sending mail, which requires a specific series of steps and appropriate stamps and marks on the envelope to deliver a letter to the correct address.

A team led by UWMadison cancer researchers Richard A. Anderson and Vincent Cryns has discovered a direct link between the p53 and PI3K/Akt pathways. The findings, published today in the journal Nature Cell Biology, identified links in the pathways that make promising targets for new cancer treatments.

We have known for some time that lipid messenger molecules that activate the PI3K/Akt pathway found in membranes are also present in the nucleus of cells, says Anderson, a professor at the UW School of Medicine and Public Health. But what they were doing in the nucleus separate from membranes was a mystery.

Mo Chen, an associate scientist and first author of the new study, used chemotherapy drugs to stress cancer cells and damage their DNA as they were replicating, or creating new copies of themselves (which cancer cells do often). She discovered that proteins called enzymes that are part of the PI3K/Akt pathway bind to the mutated p53 protein in the nucleus of the cell and attach lipid messengers to p53, showing the two are directly linked.

Instead of entering apoptosis the proactive process of cell suicide which removes damaged cells the cancer cells repaired their chemotherapy-damaged DNA and went on growing and dividing, promoting cancer growth.

These results also have critical implications for cancer treatment,

Vincent Cryns

Our finding that the PI3K/Akt pathway is anchored on p53 in the nucleus was entirely unexpected, says Cryns, a physician-scientist and professor at UW School of Medicine and Public Health.

The PI3K/Akt pathway was thought to be confined to membranes.

These results also have critical implications for cancer treatment, Cryns says. Current treatments that target PI3K may not work because they operate on a different enzyme than the one in the pathway the research team discovered.

The enzyme in the new pathway is called IPMK and rendering it inactive keeps p53 proteins from binding with and activating the Akt pathway, like correcting the address on an envelope so it doesnt go to the wrong place. This prevents the pathway from benefitting cancer cells, making IPMK a promising new drug target.

The researchers, whose work is supported by the National Institutes of Health, the Department of Defense and the Breast Cancer Research Foundation, have also identified another enzyme, called PIPKIa, that is a key regulator of both p53 and Akt activation in the cell nucleus.

The team had previously shown that PIPKIa stabilizes the p53 protein, allowing it to be active. When PIPKIa was turned off, p53 levels inside the cell fell sharply. In the new study, the team showed that blocking PIPKIa by genetic approaches or a drug triggered cancer cell death by preventing p53 from activating Akt in the cell nucleus.

What this means is that drug inhibitors of PIPKIa will reduce mutant p53 levels and block Akt activation in the nucleus, potentially a very powerful one-two punch against cancer cells, Cryns says. Their team is actively searching for better PIPKIa drug inhibitors that could be used to treat cancers with p53 mutations or abnormally active PI3K/Akt pathway.

In addition to searching for drugs to block the newly discovered cancer pathway, the scientists are investigating whether other proteins in the cell nucleus are targets of the PI3K/Akt pathway.

We know other nuclear proteins are modified by lipid messengers like p53, but we have no idea how broad the landscape is, Anderson says.

However, the evidence suggests that this could be a feature shared among many kinds of cancers, a mechanism we are calling a third messenger pathway, he adds.

This research was supported in part by grants from the National Institutes of Health (R35GM114386), the Department of Defense (W81XWH-17-1-0258, W81XWH-17-1-0259, W81XWH-21-1-0129) and the Breast Cancer Research Foundation.

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