Category Archives: Cell Therapy

A small stem cell trial in which patients with severe spinal injuriesappeared to make remarkable progress is still showing excellent results, according to the company conductingthe research.

One of the patients in the trial is 21-year-old Kris Boesen, from Bakersfield, California, whose story we reported on last year.A car crash had left theBakersfield, California native with three crushed vertebrae, almost no feeling below his neck, and a grimprognosis. Doctors believed he would live the rest of his life as a paraplegic.

Enter stem cell therapy. Most treatments for serious spinal injuries concentrate on physical therapy to expand the range of the patients remainingmotor skills and to limit further injury, not to reverse the actual damage. But last April, as part of an experimental phase 2 clinical trial called SCiStar, researchers injected Boesen with 10 million stem cells. By July, hehad recovered use of his hands to the point where he could use a wheelchair, a computer and a cellphone, and could take care of most of his daily living needs.In recent months his progress has continued, says his father.

Boesen is not the only patient to have improved in the trial, according toAsterias Biotherapeutics, which is conducting the research. Boesen is part of a cohort of six patients who were experiencing various levels of paralysis and were injected with the 10 million stem cell dose. In a Jan. 24update, the company saidfive of those patientshad improved either one or twolevels on a widely used scale to measuremotor function in spinal injury patients.

On Tuesday, Asterias issued a newupdate, announcingthat the sixth patient in the cohort has experienced a similar improvement.

While spontaneous recovery for spinal injury patients does occur,the likelihood of all six patients recovering to the degree they haveis less likely, researchers say.

This is as good as you could hope at this point, said Charles Liu, Boesens neurosurgeon and director of the USC Neurorestoration Center. So far all the evidence is pointing in the right direction.

To measure improvement in spinal injury patients, researchers use two yardsticks: the Upper Extremity Motor Scale, or UEMS, and the International Standards for Neurological Classification of Spinal Cord Injury, or ISNCSCI. On the UEMS scale,patients are scored from 0 to 5 on theirability to use five key muscles in the wrists, elbows and fingers. The ISNCSCI scale assesses where damage has occurred along the different levels of the cervical vertebrae, which generally determines the scope of impairment to the body and the level of care needed.

For instance, if a patient has sustained damage at the fourth cervical vertebra down, known as C-4, at the base of the neck, it generally means that person is paralyzed from the neck down, requiring round-the-clock care and a ventilator to breathe.A patient with a C-5 injury may not be able to move her arms or hands, requiring about 6 to 12 hours per day of assisted care; and at the C-6 level, better motor function mayallow a patient to take care of most of herdaily living needs on her own.

Which is all to say that even one level of recovery could substantially improve the daily life ofa spinal injury patient.

According to Asterias, all six patients in the 10million-cell cohort have improved their general UEMS scores, and jumped at least one motor level on the ISNCSCI scale on one or both sides of their body.

Two patients have improvedtwo motor levels on one side; and one patient,Boesen, has improved two motor levels on both sides.

Steve Cartt, president and CEO of Asterias, said anotherpatient, Jake Javier of Danville, California, has gonefrom partial paralysis to being able to use his hands well enough to considerpursuing a computer science career.

Throws Like a Regular Throw

In September, Boesens father, Rod Boesen, told us how excited he wasthat his son had regained some feeling in one of his feet. Last week, at11 months post-injection, the elder Boesensaid Kris has continued to improve.

Now he can move his toe and his knee together at the same time, Boesen said. Theyre about to give him a manual wheelchair now [instead of a motorized one]. He can grip with his hands enough to use a manual one.

Boesen said the movement in his sons arms and hands has greatlyimproved since September.Kris, a formerhigh school pitcher, had beenflinging a ball to his dog like people throw hand grenades, Boesen said. They kind of cradle them and thats how Kris would do it. But now he throws like a regular throw, tosses that ball down the hall, has that release point down, and just wings it.

Asterias is currently recruiting patients for a trial in which theyll receive 20 million stem cells, the optimal dose, according to company researchers. Two patients have already started the 20 million stem cell therapy, and six-month results from those patients will be released in the fall, Cartt said.

Patients who received 2 million stem cells in an earlier phase of the study have not shown much change in their condition, according to the Jan. 24 update.

Guarded Optimism

While Boesens father is impressed with the results, the optimism of researchers inside and outside the studyhas been guarded.The trial is still in its early stages, and the sample size is small, said Paul Knoepfler, a cell biology professor and stem cell researcher at UC Davis, who is not involved in the SCiStar study.

As a scientist, I still would want to wait for more data, Knoepfler said. Its certainly interesting, but its still early. Its a phase 2 trial.

To address the issue of small sample size, Asterias islooking at historical data to determinethe level of improvement for patients in similar circumstances who did not receive stem cell therapy. The company has said it found a meaningful difference in the recovery of its study patients compared to the norm.

Liu said one of the most importantresults is the lack of significant side effects or other negative outcomes resulting from the treatment to date.

Thats very significant to me, Liu said. Thats the first thing you look for, is anyone hurt from this therapy.

There was also a concern, he said, that some patients might regress over time, once the initial injection of stem cells wore off. Thathasyet to occur.

No one has lost anything theyve gained, Liu said. We were very happy to see that. This is all very promising.

The next step for the SCiStartrial will be to establish a control group, Cartt said.

Follow this link:
Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says - KQED

March 21, 2017 Credit: University of Bristol

Researchers have shown stem cells from the umbilical cord may hold the key to a new generation of graft and could reduce the number of surgeries required to treat young children born with certain types of congenital heart disease.

Congenital heart disease (CHD) is the most common type of birth defect. In the UK alone over 4,000 babies are diagnosed with CHD each year and thanks to advances in treatment and care, more than eight out of ten CHD babies grow up to be adults.

However, the only treatment for these conditions is corrective surgery where a piece of tissue, known as an implant, is used to replace the damaged area. Often surgery has to be repeated several times throughout childhood as the child's heart outgrows the artificial implant used to repair it.

Professors Massimo Caputo and Paolo Madeddu, in the Bristol Heart Institute, a newly created specialist research institute (SRI) at the University of Bristol, have developed cellular grafts using stem cells from the umbilical cord and placenta that are able to grow like living tissue and it is hoped would be able to grow along with a child's heart. These new grafts would mean that instead of having multiple operations to insert bigger grafts as the patient's heart grows only one operation would be needed.

These grafts have been tested in animal models that closely resemble the 'real-world' scenario and tested for their capacity to grow and regenerate the damaged heart. The researchers are also exploring which cells are best suited for the graft so that a wide range of treatment options and solutions could be tailored to the patients' needs. With the first two phases of research completed, the academics are now preparing to start a clinical trial in newborn babies.

Massimo Captuo, Professor of Congenital Heart Surgery from the School of Clinical Sciences, said: "We believe stem cells from the umbilical cord, usually discarded after birth, could hold the key to a new generation of graft. These grafts grow at the same rate as the children they're used to treat and reduce the risk of rejection after transplant as they contain the child's own DNA."

Paolo Madeddu, Professor of Experimental Cardiovascular Medicine from the School of Clinical Sciences, added: "The long-term outcomes for most young children remains poor and significantly affects their quality of life. By developing these new grafts, we hope to reduce the amount of surgeries that a child born with congenital heart disease must go through."

Explore further: Engineered blood vessels grow in lambs

In a hopeful development for children born with congenital heart defects, scientists said Tuesday they had built artificial blood vessels which grew unaided when implanted into lambs, right into adulthood.

Current cardiovascular valve or blood vessel implants are generally associated with a number of complications, have limited efficacy over time, and may necessitate repeated interventions over a patient's lifetime, especially ...

Mayo Clinic has announced the first U.S. stem cell clinical trial for pediatric congenital heart disease. The trial aims to determine how stem cells from autologous umbilical cord blood can help children with hypoplastic ...

In a first-in-children randomized clinical study, medical researchers at the University of Maryland School of Medicine (UM SOM) and the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School ...

Over one million children are born with congenital heart disease (CHD) each year. When children with CHD receive timely treatment, 85% can survive into adulthood to live healthy, productive lives. Sadly, 90% of the children ...

A new minimally invasive technique for repairing the most common cardiac birth defect in extremely premature newborns can be performed safely with a high success rate in babies as small as 755 grams - about 1.6 pounds - only ...

Moderate drinking is associated with a lower risk of several, but not all, cardiovascular diseases, finds a large study of UK adults published by The BMJ today.

A small protein that could protect the brain from stroke-induced injury has been discovered by researchers from The University of Queensland and Monash University.

ATMs and coffee shops such as Tim Hortons, Starbucks and Second Cup make ideal locations for placing automated external defibrillators (AEDs), according to a new study led by U of T Engineering researchers Professor Timothy ...

About 12 percent of patients undergoing aortic valve replacement developed non-symptomatic blood clots around the valve leaflets (known as subclinical leaflet thrombosis) that reduced the motion of the valves, according to ...

Substituting rivaroxaban for aspirin in patients with acute coronary syndromes (ACS) appears to cause no significant increase in bleeding risk, according to a study led by scientists from the Duke Clinical Research Institute ...

Researchers are revisiting their views on the relative dangers soft and hard atherosclerotic plaque deposits pose to heart health. Findings of a new study by researchers at the Intermountain Medical Center Heart Institute ...

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

View post:
Stem cell therapy could help mend the youngest of broken hearts - Medical Xpress

Science Daily

Unproven stem cell 'therapy' blinds three patients at Florida clinic Science Daily Three people with macular degeneration were blinded after undergoing an unproven stem cell treatment that was touted as a clinical trial in 2015 at a clinic in Florida. Within a week following the treatment, the patients experienced a variety of ... Regenerative Stem Cell Treatment Offers Hope for People with Rheumatoid ArthritisHealthline Unethical Stem Cell Therapy for Autism In India?Discover Magazine (blog) 3 women blinded after undergoing unproven stell cell 'therapy' - WZZMWZZM13.com BioEdge all 46 news articles »

Read the original post:
Unproven stem cell 'therapy' blinds three patients at Florida clinic - Science Daily

Thinly traded micro cap Asterias Biotherapeutics (AST +12.4%) perks up on light volume in response to its update on its ongoing SciStar Phase 1/2a clinical trial assessing the 10M-cell dose of AST-OPC1 (oligodendrocyte progenitor cells) in patients with sub-acute C-5 to C-7 cervical spinal cord injury (SCI).

Data on the sixth and final patient in the AIS-A (complete injury, no motor function below the injury site) 10M cell cohort showed upper extremity motor function improvement at month 3 and further improvement in month 6. The results were consistent with the five previous patients. Upper extremity motor function is the most desirable functional improvement in the quadriplegic population.

CEO Steve Cartt says, "These results are quite encouraging, and suggest that there are meaningful improvements in the recovery of functional ability in patients treated with the 10 million cell dose of AST-OPC1 versus spontaneous recovery rates observed in a closely matched untreated patient population. We look forward to reporting additional efficacy and safety data for this cohort, as well as for the currently-enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts, later this year."

See original here:
Asterias Bio's cell therapy continues to demonstrate treatment effect in spinal cord injury patients; shares ahead 12% - Seeking Alpha

Researchers have shown stem cells from the umbilical cord may hold the key to a new generation of graft and could reduce the number of surgeries required to treat young children born with certain types of congenital heart disease.

Congenital heart disease (CHD) is the most common type of birth defect. In the UK alone over 4,000 babies are diagnosed with CHD each year and thanks to advances in treatment and care, more than eight out of ten CHD babies grow up to be adults.

However, the only treatment for these conditions is corrective surgery where a piece of tissue, known as an implant, is used to replace the damaged area. Often surgery has to be repeated several times throughout childhood as the childs heart outgrows the artificial implant used to repair it.

Professors Massimo Caputo and Paolo Madeddu, in the Bristol Heart Institute, a newly created specialist research institute (SRI) at the University of Bristol, have developed cellular grafts using stem cells from the umbilical cord and placenta that are able to grow like living tissue and it is hoped would be able to grow along with a childs heart. These new grafts would mean that instead of having multiple operations to insert bigger grafts as the patients heart grows only one operation would be needed.

These grafts have been tested in animal models that closely resemble the real-world scenario and tested for their capacity to grow and regenerate the damaged heart. The researchers are also exploring which cells are best suited for the graft so that a wide range of treatment options and solutions could be tailored to the patients needs. With the first two phases of research completed, the academics are now preparing to start a clinical trial in newborn babies.

Massimo Captuo, Professor of Congenital Heart Surgery from the School of Clinical Sciences, said: We believe stem cells from the umbilical cord, usually discarded after birth, could hold the key to a new generation of graft. These grafts grow at the same rate as the children theyre used to treat and reduce the risk of rejection after transplant as they contain the childs own DNA.

Paolo Madeddu, Professor of Experimental Cardiovascular Medicine from the School of Clinical Sciences, added: The long-term outcomes for most young children remains poor and significantly affects their quality of life. By developing these new grafts, we hope to reduce the amount of surgeries that a child born with congenital heart disease must go through.

The research project has been funded thanks to research grants from the Sir Jules Thorn Charitable Trust, British Heart Foundation (BHF), Enid Linder Foundation, Medical Research Council (MRC), Heart Research UK and alumni of the University of Bristol.

About Bristol Heart InstituteBristol Heart Institute is one of seven newly created Specialist Research Institutes (SRIs) designed to reflect Bristols strength and depth in key specialisms.

The institute is a world-leading centre for translational cardiovascular research and the leading academic cardiac surgery centre in the UK. Specialising in preventing, predicting, detecting, reducing and treating cardiovascular disease, it brings together scientists and clinicians from across the University and the NHS in Bristol; training the next generation of cardiovascular scientists and clinical academics.

Read more:
Stem cell therapy could help mend the youngest of broken hearts - HealthCanal.com (press release) (blog)

Tapestry Senior Living is Tallahasee's newest senior living and memory care facility, located at 2516 West Lakeshore Drive, Tallahassee, FL 32312.

Freeport, Grand Bahama (PRWEB) March 21, 2017

Okyanos Cell Therapy has announced Tallahassee, FL will be the next destination for a free educational seminar as part of their live events series, Stem Cell Therapy: The Next Phase in the Evolution of Medicine. As the Bahamas first fully licensed adult stem cell facility under the 2013 Stem Cell Research and Therapy Act, Okyanos maintains a mission to help no-option patients and those with serious, progressive conditions to return to a more normal life utilizing cell therapy. The Tallahasee event will take place at Tapestry Senior Living on Saturday, April 8, 2017 at 10:00am. Pre-registration is required. If you wish to attend or learn more, please email seminars(at)okyanos(dot)com.

With stem cells existing as somewhat of a buzzword in healthcare today, questions loom as to what the true potential of stem cell-based therapies is for conditions like Parkinsons Disease, osteoarthritis and heart failure. It is through their free live education series that Okyanos works to raise awareness and bring understanding on the potential of stem cell research and treatment, as well as the importance of patient safety and proper regulation.

Residents of Tapestry Senior Living of Tallahassee as well as members of the community are invited to attend this informative discussion on the functions of adult stem cells as well as clinical research and observations. Guests will hear from Moira T. Dolan, MD, who serves as a Patient Consultant at Okyanos. Dr. Dolan will provide an overview of how the stem cells present in body fat (adipose tissue) can be used to address chronic, degenerative conditions and help patients return to a more normal life.

My role at Okyanos and generally as a physician is to understand each of my patients individual challenges and needs, and to advocate for them as they make treatment choices, said Dr. Dolan, who is a diplomate of the American Board of Internal Medicine and holds certification with the American Board of Anti-Aging and Regenerative Medicine. Through our live events I enjoy the opportunity to discuss the promise of adult stem cell treatment for a wide range of conditions and share some of what we are seeing in our patients at Okyanos who have undergone our evidence-based treatment protocols.

We are very excited to have Okyanos at our facility for this event, said Mackenzie Hellstrom, Director of Sales and Marketing at Tapestry Senior Living. In Okyanos approach to personalized medicine and our emphasis on person-centered care, we saw an opportunity to work together and provide an enriching experience for our residents and the community with this information about adult stem cells.

For more information, please contact Okyanos by calling 855-OKYANOS (659-2667) or via email: seminars(at)okyanos(dot)com. Seating is limited for this event.

ABOUT OKYANOS CELL THERAPY: (OH KEY AH NOS)

Combining state-of-the art technologies delivered in the first cell therapy center of excellence in the world, Okyanos is a leading adult stem cell therapy provider. Okyanos Cell Therapy helps people living with chronic, degenerative diseases return to a more normal life through a treatment approach using fat-derived stem cells. Based in Freeport, Grand Bahama, Okyanos is fully licensed under the Bahamas Stem Cell Therapy and Research Act and adheres to U.S. surgical center standards. The literary name Okyanos, the Greek god of the river Okeanos, symbolizes restoration of blood flow. Learn more at http://www.okyanos.com.

Share article on social media or email:

Read the original here:
Okyanos Cell Therapy Brings Stem Cell Education to North Florida - PR Web (press release)

Science Daily

Stem cell therapy is safe for stroke patients, study shows Science Daily It was those longer-term results, particularly in the small number of patients who got therapy early, that suggested the cell therapy group might be more likely to continue to recover, with reduced disability and fewer infections one year out than the ... Cancer Stem Cell Therapy Market Share, Trends, Opportunities & Forecast 2017-2022Medgadget (blog) all 5 news articles »

Continue reading here:
Stem cell therapy is safe for stroke patients, study shows - Science Daily

TORONTO, ON--(Marketwired - March 20, 2017) - During an informative session on Wednesday, April 5, 2016, industry experts from Fisher BioServices, Kristen Franklin, Client Services Manager and Amy Hendricks, Project Manager will review some of the key components to consider when developing a strategy to minimize risk, manage cost, and ultimately deliver a product to market.

The success of developing a cellular therapy rests on the ability to deliver a viable, potent product. This positive end-result is directly attributable to the strategy in place and the supporting processes. A reliable cell therapy development strategy is imperative to ensuring your therapeutic materials remain viable from the point of collection, through manufacture, to the final clinical site delivery.

Key Learning Objectives:

For more information or to register for this complimentary event, visit: Cell Therapy - Achieving Success on the Road to Commercialization

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.comFor information about hosting a webinar visit http://xtalks.com/sponsorship.ashx

Image Available: http://www.marketwire.com/library/MwGo/2017/3/16/11G133366/Images/FS_FisherBioservicesLogo_jpg-c38c171e22a29358b262fb8c868c1c82.jpg

Excerpt from:
Cell Therapy -- Achieving Success on the Road to ... - Marketwired - Marketwired (press release)

March 20, 2017 by Melissa Gaskill Cultured stem cells. Credit: BioServe Inc., University of Colorado

Growing significant numbers of human stem cells in a short time could lead to new treatments for stroke and other diseases. Scientists are sending stem cells to the International Space Station to test whether these cells proliferate faster in microgravity without suffering any side effects.

Therapeutic uses require hundreds of millions of stem cells and currently no efficient way exists to produce such quantities. Previous research suggests that microgravity could help, and the space station is home to the nation's only national lab in microgravity.

Some types of stem cells grow faster in simulated microgravity, according to Abba Zubair, a researcher at the Mayo Clinic in Jacksonville, Florida. Zubair is principal investigator for the Microgravity Expanded Stem Cells investigation, which is cultivating human stem cells aboard the space station for use in clinical trials back on Earth. He holds a doctor of medicine degree in transfusion medicine and cell therapy and a doctorate of philosophy in tumor immunology.

Human stem cells are cells that have not yet specialized in function and can divide into a spectrum of cell types, rejuvenating and repairing tissue throughout a person's lifetime. Stem cells in every organ of the body, including skin and bones, maintain those organs and repair tissue by dividing and differentiating into specialized cells.

Harvesting a person's stem cells and growing enough of them for use in therapies has proven difficult, though. Researchers have successfully grown mesenchymal stem cells, found in bone marrow, but growing sufficient quantities takes weeks. That could be too late for treatment of some conditions.

"Stem cells are inherently designed to remain at a constant number," Zubair explains. "We need to grow them faster, but without changing their characteristics."

The first phase of the investigation, he adds, is answering the question: "Do stem cells grow faster in space and can we grow them in such a manner that they are safe to use in patients?"

Investigators will examine the space-grown cells in an effort to understand the mechanism behind microgravity's effects on them. The long-term goal is to learn how to mimic those effects and develop a safe and reliable way to produce stem cells in the quantities needed.

The second phase will involve testing clinical application of the cells in patients. Zubair has been studying treatment of stroke patients with lab-grown stem cells and plans to compare those results with use of the space-grown stem cells.

"What is unique about this investigation is that we are not only looking at the biology of the cells and how they grow, but focusing on application, how we can use them to treat patients," he says.

The investigation expands existing knowledge of how microgravity affects stem cell growth and differentiation as well as advances future studies on how to produce large numbers of stem cells for treating stroke and other conditions.

The faster that happens, the better for those who could benefit from stem cell therapies.

Explore further: Study shows adipose stem cells may be the cell of choice for therapeutic applications

An international team of researchers, funded by Morris Animal Foundation, has shown that adipose (fat) stem cells might be the preferred stem cell type for use in canine therapeutic applications, including orthopedic diseases ...

Abba Zubair, M.D., Ph.D, believes that cells grown in the International Space Station (ISS) could help patients recover from a stroke, and that it may even be possible to generate human tissues and organs in space. He just ...

Consider it one physician's giant leap for mankind. Today, the latest rocket launch from NASA's Kennedy Space Center in Cape Canaveral, Florida, included a payload of several samples of donated adult stem cells from a research ...

NASA and the Center for the Advancement of Science in Space (CASIS) are enabling research aboard the International Space Station that could lead to new stem cell-based therapies for medical conditions faced on Earth and in ...

A study performed on the NASA Space Shuttle Discovery showed that exposure of mouse embryonic stem cells (mESCs) to microgravity inhibited their ability to differentiate and generate most cell lineages, needed for the development ...

Stem cells hold great promise for transforming medical care related to a diverse range of conditions, but the cells often lose some of their therapeutic potential when scientists try to grow and expand them in the laboratory. ...

As children, we learned about our solar system's planets by certain characteristicsJupiter is the largest, Saturn has rings, Mercury is closest to the sun. Mars is red, but it's possible that one of our closest neighbors ...

(Phys.org)Astronomers have inspected a mysterious isolated star cluster complex designated SH2 in the galaxy NGC 1316 (also known as Fornax A). The results of their study, which were published Mar. 1 in a paper on arXiv.org, ...

Growing significant numbers of human stem cells in a short time could lead to new treatments for stroke and other diseases. Scientists are sending stem cells to the International Space Station to test whether these cells ...

Astronomers studying Mars first noted the presence of yellow clouds on its surface in the 1870's. Today these windblown dust storms on Mars are well known, and can span local, regional or even global in scale. Storms can ...

A SpaceX reusable cargo ship splashed down in the Pacific Ocean safely on Sunday, ending a mission to supply astronauts on the International Space Station, the company said.

Johns Hopkins University scientist Kirby Runyon wants to make one thing clear: Regardless of what one prestigious scientific organization says to the contrary, Pluto is a planet. So is Europa, commonly known as a moon of ...

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Link:
Stem cells seem speedier in space - Phys.Org

April Stevens , WZZM 12:08 PM. EST March 19, 2017

Close up of an eye surgery, stock image. (Photo: Thinkstock)

SANFORD, CALIF. - Three women with macular degeneration were blinded after an unproven stem cell treatment described as a "clinical trial."

A recent paper published in The New England Journal of Medicine documents the cases and is a "call to awareness for patients, physicians and regulatory agencies" on minimally regulated, patient-funded research according to Jeffrey Goldberg, MD, PhD, professor and chair of ophthalmology at the Stanford University School of Medicine and co-author of the paper.

Three patients -- all women ranging in age from 72 to 88 -- suffered from macular degeneration, a common disease of the retina that leads to loss of vision over time. Before the patients underwent surgery, their vision ranged from 20/30 to 20/200.

Now, all three patients are likely to remain blind due to complications from the stem cell treatments.

"Although I can't say it's impossible, it's extremely unlikely they would regain vision," said co-author Thomas Albini, MD,an associate professor of clinical ophthalmology at the University of Miami, where two of the patients went to treat complications.

The trial appealed to patients 'desperate for care'

Two of the patients learned of the so-called clinical trial on ClinicalTrials.gov, a registry and results database run by the U.S. National Library of Medicine. The patients believed they were participating in a trial, although the consent form and other written materials given to the them did not mention a trial, Albini said.

"There's a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous," Albini said.

Each patient paid $5,000 for the procedure, which authors said should have raised a red flag.

"I'm not aware of any legitimate research, at least in ophthalmology, that is patient-funded," Albini said.

At the Florida clinic where the procedure took place, patients have fat cells removed from their abdomens and a standard blood draw. The fat tissue was processed in a lab with the goal of obtaining stem cells and platelet-dense plasma was isolated from the blood. The cells were then mixed with the plasma and then injected into their eyes.

Patients reported that the entire process took less than an hour. The patients had both eyes treated at once -- another red flag, Albini and Goldberg said, because most doctors would opt to see how one eye responds to an experimental treatment before attempting the other eye.

No evidence the procedure would have restored vision

Shoddy stem cell preparation may have led to some of the complications, Albini said. However, even if executed correctly, there is no evidence that the procedure could have help to restore vision both authors report.

There is sparse evidence that fat-derived stem cells, the kind that the clinic claimed to use, are capable of differentiating, or maturing, into the kind of cells that researchers are attempting to target to develop therapies that could slow down macular degeneration.

"There is a lot of very well-founded evidence for the positive potential of stem therapy for many human diseases, but there's no excuse for not designing a trial properly and basing it on preclinical research," Goldberg said.

The "trial" lacked nearly all of the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, assignment of a control group and treatment group, collection of data, masking of clinical and patient groups, and plans for follow-up, Goldberg and Albini said.

Listings on ClinicalTrials.gov are not fully scrutinized for scientific soundness, Goldberg said. Although still visible on the website, the listing now states: "This study has been withdrawn prior to enrollment."

Albini says the clinic is also no longer performing these eye injections, but still seeing patients.

The procedures were not subject to Food and Drug Administration approval because the cells were not transferred between patients and were considered "minimally processed," according to Title 21, Part 1271.10, of the Code of Federal Regulations. The FDA released more specific guidelines in October 2015, after these procedures were performed, establishing the requirement for FDA oversight and approval for these types of procedures.

'Lack of oversight can lead to bad players and bad outcomes'

"We expect health care providers to take every precaution to ensure patient safety, but this definitely shows that the lack of oversight can lead to bad players and bad outcomes. It's alarming," Albini said.

The authors acknowledged that it is difficult for patients to know whether a clinical trial, or a stem cell therapy, is legitimate. Goldberg recommended that patients considering a stem cell treatment consult a website, A Closer Look at Stem Cells, run by the International Society for Stem Cell Research and to check if the trial is affiliated with an academic medical center.

More information about this paper can be found here. You can read the paper here.

Makeit easy to keep up to date with more stories like this.Download theWZZM13 app now.

April Stevensis a multi-platform producer. Have a news tip? Emailnews@wzzm13.com, visit ourFacebook pageorTwitter.

2017 WZZM-TV

See the rest here:
3 women blinded after undergoing unproven stell cell 'therapy' - WZZM13.com