Yearly Archives: 2017


Stem Cell Clinic > 2017

Stem cell therapy blinds 3 women in US – Tempo

By Stem Cell Treatment

SAN FRANCISCO (PNA/Xinhua) An ophthalmologist in the United States calls for increased patient education and regulation after three patients were blinded following a treatment marketed as a stem cell clinical trial.

A recent paper documenting the cases was co-authored by Jeffrey Goldberg, professor and chair of ophthalmology at the Stanford University School of Medicine, and published in The New England Journal of Medicine, a publication of the Massachusetts Medical Society as one of the most prestigious peer-reviewed medical journals in the world.

The three patients are all women, ranging in age from 72 to 88. They suffered from macular degeneration, a common, progressive disease of the retina that leads to loss of vision. Before the surgery, the vision in their eyes ranged from 20/30 to 20/200, meaning they can read at 20 feet, or about 6 meters, a letter that people with normal vision can read from 30 to 200 feet, or about 9 meters to 60 meters.

Now, the patients are likely to remain blind, said co-author Thomas Albini, an associate professor of clinical ophthalmology at the University of Miami, where two of the patients were treated for complications from the stem cell treatments.

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, where it was called Study to assess the safety and effects of cells injected intravitreal in dry macular degeneration.

Each patient paid 5,000 U.S. dollars for the procedure. Any clinical trial that has a fee should raise a red flag, said the authors, with Albini adding Im not aware of any legitimate research, at least in ophthalmology, that is patient-funded.

At the clinic in Florida, which is not named in the paper, the patients had fat cells removed from their abdomens and a standard blood draw. The fat tissue was processed with enzymes, with the goal of obtaining stem cells. Platelet-dense plasma was isolated from the blood. The cells were then mixed with the platelet-dense plasma and injected into their eyes. Patients reported that the entire process took less than an hour, Albini said.

Excerpt from:
Stem cell therapy blinds 3 women in US - Tempo

Beware the hype on stem-cell breakthroughs – The Globe and Mail – The Globe and Mail

By Stell Cell Research

Health science gets a lot of attention in the popular press. People love hearing about breakthroughs, paradigm shifts and emerging cures. The problem is, these stories are almost always misleading.

While optimistic miscalculations of the state of biomedical research may seem as if it were a harmless distraction, there is a growing body of evidence that suggests it can be the source of real social harm. It can drive unrealistic expectations, affect the public utilization of health-care resources and even shape a less-than-ideal research agenda. It can also help to legitimize the marketing of unproven therapies.

This week, the New England Journal of Medicine (NEJM) reported on three individuals who went blind after receiving an unproven stem cell treatment at a Florida clinic. The patients paid thousands of dollars for what they thought was a clinical trial on the use of stem cells to treat macular degeneration.

The primary fault, both legally and morally, for the marketing and use of unproven stem-cell therapies lies with the providers who are involved with the practice. We need national regulators (e.g., Health Canada, the U.S. Food and Drug Administration) and the bodies that oversee the relevant health-care professionals (e.g., the colleges that regulate physicians) to take a more active role a point noted by Dr. George Daley in an essay accompanying the NEJM case report.

Indeed, it is hard to blame patients for being drawn to providers that present optimistic portrayals of benefit. We live in confusing times. It is becoming increasingly difficult to tease out the real science from the bad and the fake health news from a genuinely exciting scientific advance. Not only is the science twisted by multiple systemic forces publication pressures, overenthusiastic news releases, commercial interests and media spin misinformation is being broadcast on a growing number of communication platforms. Social media, for example, have allowed for the rapid dissemination of false promises and creation of confirmation bubbles in which like-minded believers can trade anecdotes of success. And studies have shown clinics exploit platforms such as Twitter to create buzz about and demand for unproven therapies.

For the general public, here is a good rule of thumb: Doubt every claim that suggests a significant breakthrough. Doubt everything. This may sound a tad cynical, but if you adopt this approach you will be pleasantly surprised when something actually pans out. More important, this nothing-ever-works-as-promised strategy will be correct 99 per cent of the time.

For patients seeking a treatment, be cautious of any clinic offering a therapy that seems too good to be true, because virtually every time it will be too good to be true.

Consider stem-cell research. Think of all the hype, the headlines about near-future applications and the pronouncement about revolutionary regenerative therapies. This hand waving has been going on for almost two decades. So much so that the phrase stem cells has morphed into cultural marker for cutting edge. But despite all this unrelenting, upbeat noise, there are very few stem-cell therapies that are currently ready for clinical application. Daley, who is a renowned stem-cell researcher and the current dean of Harvard Medical School, concludes there are just a handful: those used for the blood-related ailments and for the skin (epithelium) conditions. The International Society for Stem Cell Research agrees with Daley and notes the list of diseases for which stem-cell treatments have been shown to be beneficial is still very short.

Dont get me wrong; I believe stem-cell research remains a fantastically promising area of science. But true medical breakthroughs are rare. Incredibly rare. In fact, if a study claims a large effect size, which is often the case in stories about breakthroughs, there is a good chance the results will be overturned by subsequent work. In a well-known 2003 analysis, it was found that out of 101 studies published between 1979 and 1983 in top science journals and framed as clinically promising interventions, only one was used extensively for the licensed indications (yes, about 99 per cent of the peer-reviewed predictions were wrong). The authors concluded that even the most promising findings of basic research take a long time to translate into clinical experimentation, and adoption in clinical practice is rare.

Yes, we need regulators to crack down on the marketing of unproven stem-cell therapies. As demonstrated by these recent reports of treatment-induced blindness, these clinics can cause serious harm. But we also need to do our best to curb the science noise that helps to legitimize the false claims made by the purveyors of stem-cell products. Scientists, clinicians, policy makers and journalists should do their best to counter misinformation in all its forms.

More good science, less science-y noise.

Timothy Caulfield is Canada Research Chair in Health Law and Policy at the University of Alberta, a Trudeau Fellow and author of Is Gwyneth Paltrow Wrong About Everything?

This story first appeared in Healthy Debate, an online publication guided by health-care professionals and patients that covers health policy and evidence-based medicine in Canada.

Follow us on Twitter: @Globe_Health

Read more here:
Beware the hype on stem-cell breakthroughs - The Globe and Mail - The Globe and Mail

New research shows promise for the production of patient-matched blood cells for therapies, disease modeling and … – Science Daily

By Stell Cell Research

The Galat laboratory at Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, has developed an elegant system to derive blood cell precursors from human pluripotent stem cells (hPSC). This type of stem cell has the potential to develop into many different kinds of cells in the body, and is capable of participating in organ repair and function. These qualities have prompted scientists to test the use of hPSC to treat some diseases. However, the development of a fully defined system to generate functional blood cell precursors has proven to be a significant challenge. The Galat lab's findings hold promise to overcome this challenge.

The approach is reliable, cost-effective and relatively simple. By eliminating variables used in other systems, the lab has streamlined the process of developing blood cell precursors. This allows scientists to study the factors that affect early stages of blood cell development, and provides a mechanism for clinician-researchers to develop therapies for patients.

In a series of experiments, the lab converted adult skin cells into hPSC and then used these patient specific cells to optimize their platform of blood cell precursor derivation. Various assays were employed in order to demonstrate the ability of blood cell precursors to form mature cells of blood lineage. The cells were identified in collaboration with immunology labs at Lurie Children's and Rosalind Franklin University.

A description of the work, entitled "Cytokine Free Directed Differentiation of hPSC Efficiently Produces Hemogenic Endothelium With Lymphoid Potential," is published online in the journal Stem Cell Research & Therapy. Previously, scientists have relied on the introduction of external factors -- proteins or cells -- to induce hPSC to differentiate. In addition to potentially changing the outcomes, these factors can complicate the experimental setup and cause inefficiencies or bias in the generation of blood cell precursors.

"We designed the platform to exclude as many factors that can cause variability in the differentiation outcome as possible. These factors include co-culturing the hPSC with non-human animal cells that secrete an un-measurable amount of substances into the media, which is used to promote differentiation. We also excluded cytokines -- proteins that affect hPSC differentiation in various ways depending on their quality," says Yekaterina Galat, first author on the publication. "We demonstrated that the unique approach we developed efficiently promotes differentiation of hPSC to blood cell precursors, while eliminating many complications," she continues.

Co-senior author Philip M. Iannaccone, MD, PhD, says, "Importantly, this novel induction system, grown on one layer, avoids unwarranted effects associated with cellular interactions that happen in 3D cultures, as well as excessive priming by multiple cytokines, which complicates studies of developmental and functional aspects of the formation of blood cells, and their specifications." Iannaccone is Professor of Pediatrics at Northwestern University Feinberg School of Medicine and director of the Developmental Biology Program at the Manne Research Institute.

Says corresponding author and laboratory director Vasil Galat, PhD, "Our hope is to leverage this platform so that we can help other scientists and clinicians. The cells we derive can be used to study factors for their effects on hPSC differentiation, paving the way for studies of drug efficacy and toxicity, and to model diseases. We envision, for example, the ability to take blood cells from a patient, correct the genetic defects in the lab, and then re-introduce them into the patient. It is hoped that processes such as this can be used to treat blood disorders."

Galat's lab is currently working with Ramsay Fuleihan, MD, an attending physician in the Division of Allergy and Immunology and the director of Primary Immunodeficiency Clinical Services at Lurie Children's, on a project to derive patient cells, fix the mutation causing immune deficiency and differentiate the cells into healthy blood lineage.

Follow this link:
New research shows promise for the production of patient-matched blood cells for therapies, disease modeling and ... - Science Daily

A Groundbreaking Stem Cell Treatment Just Prevented a Woman From Going Blind – Futurism

By Stell Cell Research

In Brief

Macular degeneration affects more than 10 million people in the U.S., and is the most common cause of vision loss. It is caused by the deterioration of the middle of the retina, called the macula. The macula focuses central vision and controls our ability to see objects in fine detail, read, recognize colors and faces, and drive a car. Until now, the disease has been considered incurable.

An octogenarian with the condition is now the first person to receivesuccessful treatmentwith induced pluripotent stem (iPS) cells. The progression of the womans macular degenerationwas arrested by new retinal cells made in the lab.Unlike embryonic stem cells, iPS cells can be created from regular adult cells.In this case, the cells used to repair the damaged retina from macular degeneration came from the womansskin.

The team at Kobe, Japans RIKEN Laboratory for Retinal Regeneration, led by Masayo Takahashi, created iPS cells from the patients skin cells. Then, theyencouraged them to form cells to patch the retinal pigment epithelium. These cells help nourish and support the retina, allowing it to capture the light the eye needs to see.

Once the cells were transformed, the team used them to make a slither measuring 1 by 3 millimeters. This was the patch they used to replace the diseased tissue removed from the patients retina. Their aim was to stop the degeneration and save her sight. The results show that the procedure was technically a success: although her vision did not improve, the degeneration stopped.

A possible concern about this treatment, however, is that creating new tissues from stem cells could cause genetic mutations, which might in turnlead to cancer. While more research in this area and its possible applications is needed, in the case of the patient at RIKEN, therehave been no signs of cancer or any other complications.

Original post:
A Groundbreaking Stem Cell Treatment Just Prevented a Woman From Going Blind - Futurism

After 3 Women Are Blinded, This Controversial Procedure Is Back in the Spotlight – NewBeauty Magazine (blog)

By Stell Cell Research

A new report published by the New England Journal of Medicine details that three women have become permanently blinded after undergoing stem cell injections into their eyes at a Florida clinic. The three subjects were suffering from macular degeneration, an age-related eye disease that leads to vision impairment, and were under the impression that they were participating in a clinical trial for treatment of the disorder. In reality, these women had undergone the procedure at an unregulated Florida clinic called US Stem Cell, where staffers extracted stem cells from the womens belly fat via liposuction and then injected them into the eyes.

Stem cell treatments, although buzzy (youve heard about them in the context of being able to treat a myriad of disorders and even incorporated into skin care products) are largely unregulated, making it difficult for consumers to differentiate between solid medical research versus marketing hype. While there is plenty of legitimate research being done in the spacesome very promisingtherapy centers that lack safety standards or sufficient medical knowledge are commonplace.

You May Also Like: What You Need to Know About the New Botox Bill

According to Westchester, NY, oculoplastic surgeon James Gordon, MD, stem cell injections could potentially offer ocular benefits including treatment for corneal disease and optic nerve problems, but isnt considered the most conventional approach for treating common eye disorders. Macular degeneration is usually a slowly progressive disorder, he says. The disease progress can be slowed down further with intake of antioxidant vitamins, sunglasses and green leafy vegetables, and in more severe cases, by injecting certain medications directly into the eye.

Montclair, NJ, plastic surgeon Vincent Giampapa, MD, says that there are some promising uses for stem cell treatments with a track record of good results and years of research behind them, but the use of stem cell treatments for macular denegation is still very new and experimental at the moment.

To date, there is only one FDA-approved stem cell product, which is used to treat specific blood disorders and the agency advises those considering stem cell treatment for other uses to only participate in FDA-regulated clinical studies.

If patients want to consider stem cell therapy for a disease, they should go to ClinicalTrials.gov and look for specific trials that are approved by the government with an IRB (independent review/ethics board) study, says Dr. Giampapa. This is the only legitimate way to find a study that is being run in an approved fashion and with the appropriate safety factors in place.

When patients are considering an unconventional approach to treating a medical condition they should first investigate approved treatment options. If none of these seem particularly promising, then it's reasonable to explore other alternatives, adds Dr. Gordon. The credentials of the doctors involved need to be known. Previous results and complications of the treatment need to be carefully reviewed. Potential risks are very important to consider. When the risks of poor outcomes outweighs the potential benefits, the patient might be wise not to pursue the treatment. Second and third opinions from physicians not involved should be sought.

Read more here:
After 3 Women Are Blinded, This Controversial Procedure Is Back in the Spotlight - NewBeauty Magazine (blog)

Lactate may be key for cancer development – Medical News Today

By Uncategorized

Researchers are working hard to understand the mechanism responsible for oncogenesis, the process through which normal cells become cancerous ones. A new study focuses on lactate - a molecule produced during intense exercise - and explains its role in cancer cell formation.

New research, published in the journal Carcinogenesis, analyzes the role of lactate in oncogenesis.

Lactate is a byproduct of the chemical process known as glycolysis - the breaking down of sugar, or glucose, into smaller molecules with the purpose of producing energy. During intense physical activity, lactate accumulates in the tissue and blood, which can sometimes lead to poorer physical performance and muscle stiffness.

At the beginning of the 20th century, German scientist Otto Warburg noticed that cancer cells consume a lot more glucose than normal cells. The so-called Warburg effect refers to the fact that cancer cells undergo more glycolysis and produce more lactate compared with normal cells.

The new research - led by Inigo San Millan, director of the Sports Performance Department and physiology laboratory at the University of Colorado-Boulder's Sports Medicine and Performance Center - set out to understand why the Warburg effect happens. Since Warburg's time, the focus in cancer research has shifted from cell metabolism to genetics, but the new paper hopes to put lactate back at the center of cancer research.

San Millan and colleagues suggest that the molecule is "the only metabolic compound involved and necessary" in the five stages that follow on from carcinogenesis.

The study examines the role of lactate in angiogenesis (the process by which new blood vessels form inside the tumors), immune escape (the cancer cells' ability to elude the body's immune response), and cell migration, as well as in metastasis and self-sufficient metabolism.

The paper explains how in metastasis, lactate helps to create an acidic microenvironment outside the cancer cell, which supports the spread of cancer cells.

Finally, the study also explores the link between lactate and genetic components. The researchers hypothesize that a triad of transcription factors commonly found in most cancers - HIF-1, cMYC, and p53 - also triggers and perpetuates lactate deregulation.

The crucial role of lactate in cancer cell formation may explain why people who exercise regularly are at a lower risk of developing cancer. In athletes and those who work out, the body is trained to efficiently turn lactate into an energy source for the body, thus stopping it from accumulating in excess.

Based on their findings, the researchers speculate that a sedentary lifestyle, combined with too much sugar in our diets, may lead to an excessive accumulation of lactate, thus setting the stage for cancer.

"With this paper, we open a whole new door for understanding cancer, showing for the first time that lactate is not only present, but mandatory for every step in its development."

Inigo San Millan

In the near future, San Millan will collaborate with the University of Colorado Hospital to study the effect of tailored exercise programs on cancer patients. The researcher is already studying breast cancer cell lines.

San Millan hopes that, eventually, his research will help to develop drugs that stop the lactate from accumulating. "We hope to sound the alarm for the research community that to stop cancer you have to stop lactate," he says. "There are many ways to do that," such as by targeting monocarboxylate transporters, which ferry lactate from cell to cell.

Learn how vitamin C can target and kill cancer stem cells.

View post:
Lactate may be key for cancer development - Medical News Today

Medical News Today: Immune cell may turn heart inflammation into heart failure – Concord Register

By Uncategorized

Heart inflammation, or myocarditis, is a disorder usually caused by an infection reaching the heart. Although the condition is rare, it can sometimes lead to dilated cardiomyopathy a leading cause of heart failure in younger adults. New research helps to explain why this happens in some cases and not others, by examining an immune cell that appears to cause heart failure in mice. New research shows how heart inflammation can progress into heart failure in mice.

occurs when an infection has reached the heart. During an infection, the bodys immune system produces disease-fighting cells but in heart , these cells enter the heart and can damage its muscle.

The condition is not often diagnosed; it rarely causes severe symptoms and detecting it requires a a rather invasive procedure of moderate risk.

In some cases, myocarditis progresses into inflammatory (DCMi) a disorder in which the hearts muscle dilates, weakens, and can no longer properly pump blood. In the United States, DCMi is one of the of among younger adults, with a prevalence of between 300 and 400 patients per million U.S. adults.

New research, led by Dr. Daniela Cihakova from the Johns Hopkins University School of Medicine in Baltimore, MD set out to understand why in some cases the heart heals from the inflammation, while in others it progresses into DCMi.

As the authors of mention, previous studies have pointed to the role of eosinophils a specific type of immune cell in the development of . As Dr. Cihakova explains, the new research provide[s] more details about how these immune system cells may lead to deterioration of heart muscle function in mice in a way that lets us draw some parallels to human disease processes.

The findings were published in The Journal of Experimental Medicine.

Dr. Cihakova and colleagues genetically modified a group of mice to have a deficiency of eosinophils. They then induced myocarditis in this group, using a technique called experimental autoimmune myocarditis. In this procedure, mice receive a peptide from their heart muscle cells, which makes the bodys immune system attack the heart.

The researchers also induced myocarditis in another group of normal mice, with a healthy level of eosinophils. After 21 days, the scientists measured the inflammation in the hearts of both groups of mice.

They also analyzed the hearts for fibrosis or scar tissue both signs of dying heart muscles in mammals. Scar tissue is also present in cases of DCMi.

The scientists found similarly acute inflammation in both groups.

However, when the scientists examined the groups for signs of heart failure, they found drastic differences between the eosinophil-deficient group and the normal group.

The mice with normal levels of eosinophils went on to develop heart failure, whereas the mice with eosinophil deficiency displayed no signs of heart malfunction.

The team also found scar tissue in both groups to a similar degree. However, the normal mice had DCMi, while the eosinophil-deficient ones were not affected.

To see if they could replicate their findings, the team designed an additional experiment in which they genetically modified mice to have an excess of an eosinophil-producing protein called IL5.

The IL5-excessive mice developed more inflammation and more scar tissue in the hearts upper chambers (or atria) compared with normal mice.

Mice with excessive IL5 protein also had more heart-infiltrating cells. As much as 60 percent of these cells were eosinophils in the IL5-excessive mice, compared with only 3 percent in the normal mice.

Additionally, the researchers examined the mices hearts 45 days after the experiment and found severe DCMi in the mice with too much IL5 protein.

Finally, to account for the possibility that it is the IL5 protein and not the eosinophils that drive DCMi development, the team genetically modified eosinophil-deficient mice to have an excess of the protein.

The researchers found no reduction in the heart function of these IL5-excessive, eosinophil-deficient mice, compared with normal mice. This confirms that it is the immune cells, not the protein, that causes DCMi.

In an attempt to understand exactly how eosinophils are responsible for DCMi, the researchers investigated further and managed to isolate a protein called IL4, which is produced by eosinophils.

Using yet another mouse model, Dr. Cihakova and team established that it is indeed the IL4 that facilitates the development of DCMi, and which is triggered by eosinophils.

The take-home message is that inflammation severity does not necessarily determine long-term disease progression, but specific infiltrating cell types eosinophils, in this case do.

Dr. Daniela Cihakova

The studys senior author points out that their study is the first one to investigate the role of eosinophils in the onset of heart inflammation, and in its development from inflammation to DCMi.

Nicola Diny, a Ph.D. student in the Bloomberg School of Public Health and the studys first author, also comments on the findings:

Our studies show that the presence of eosinophils in the heart makes mice more likely to get DCMi following myocarditis. And if there are a lot of eosinophils, the mice develop even more severe heart failure, Diny says. It will be important to test if the same is true in patients. That way, we may be able to intervene early and prevent DCMi.

The researchers hope that their study will help to develop IL4-targeting medicines that could one day treat people with myocarditis, thus potentially halting its progression into DCMi.

.

Written by

Read the original here:
Medical News Today: Immune cell may turn heart inflammation into heart failure - Concord Register

Stem cell therapy helps patients with osteoarthritis – Palm Beach Post – Palm Beach Post

By Stem Cell Treatment

New treatments and advances in research are giving new hope to people affected by Osteoarthritis pain and symptoms. Dr. Theofilos provides stem cell therapy for osteoarthritis to help those achieve better health and live life in motion.

Stem cell therapy for osteoarthritis is being studied for efficacy in improving the complications in patients through the use of their own stem cells. These procedures may help patients who dont respond to typical drug treatment, want to reduce their reliance on medication, or are looking to try stem cell therapy due to pain or discomfort.

Osteoarthritis, also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking and sometimes an effusion. When bone surfaces become less well protected by cartilage, bone may be exposed and damaged. As a result of decreased movement secondary to pain, regional muscles may atrophy, and ligaments may be affected.

Stem cell treatment is designed to target these areas within the joints to help with the creation of new cartilage cells. Mesenchymal stem cells are multipotent and have the ability to differentiate into cartilage called (chondrytes). The goal of each stem cell treatment is to inject the stem cells into the joint to create cartilage.

Its expected that results of the therapy will vary depending upon the many factors of the severity, patients overall health, nutritional state and immune function. Stem cell therapy is safe and effective in reducing pain and improving function for many patients.

Voted as one of America's Top Surgeons, Charles S. Theofilos, MD, Neurosurgeon and Founder of The Spine Center is a leading provider of the state-of-the-art, most comfortable and effective surgical, minimally invasive and non-surgical treatment options for a full range of cervical and spinal ailments, including stem cell therapy and artificial disc replacement. He was among a field of 20 top neuro and orthopedic surgeons in the U.S. chosen to participate in the groundbreaking Artificial Disc Study, which compared the clinical outcome of disc replacement versus traditional spinal fusion. A widely sought after educator and lecturer, Dr. Theofilos has offices in Palm Beach Gardens and Port St. Lucie.

_______________________________________________________________

11621 Kew Gardens Ave., Suite 101; Palm Beach Gardens

*In an effort to maintain and honor the commitment to our patients, we will continue to accept Medicare and Medicare Advantage insurance plans for all new and follow up appointments.

See the rest here:
Stem cell therapy helps patients with osteoarthritis - Palm Beach Post - Palm Beach Post

3 women blinded after undergoing unproven stell cell ‘therapy’ – WZZM – WZZM13.com

By Stell Cell Research

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

Read more from the original source:
3 women blinded after undergoing unproven stell cell 'therapy' - WZZM - WZZM13.com

→←