Category Archives: Stem Cell Clinics

‘Stem cell’ therapies offered at private clinics need to …

Dr. Mark Berman injects a patient with a solution he says is rich in adult stem cells at his practice in Beverly Hills, Calif., in this December 2014 file photo.

This is an excerpt from Second Opinion, a weekly roundup of eclectic and under-the-radar health and medical science news emailed to subscribers every Saturday morning. If you haven't subscribed yet, you can do that by clicking here.

Canada's direct-to-consumer cell therapyindustry is thriving.

Across the country, private clinics continue to sell expensive procedures advertised as a form of "regenerative medicine."

The clinics use what they claim are stem cellsthat are siphoned from a patient's bone marrow or fat tissue and injected or given intravenously to treat a range of conditions including joint pain, multiple sclerosisand nerve disorders.

There is a lack of clinical trial evidence to determine whether the procedures are safe and effective. And there has been a long-running debate about whether they're legal.

This week Health Canada issued a public policy position on that point.

"All cell therapies are considered drugs under the Food and Drugs Act. This means that they must be authorized by Health Canada to ensure that they are safe and effective before they can be offered to Canadians," Health Canada said in a news release.

That policy statement confirms that cell therapies are not legal in Canada unless they've been formally approved as drugs, after going through a rigorous review. And so far Health Canada has not approved any of the direct-to-consumer treatments.

Health Canada also warned Canadians about potential safety risks.

"Unauthorized treatments have not been proven to be safe or effective and may cause life-threatening or life-altering risks, such as serious infections."

If these procedures are not approved, and might not be safe, are they still happening? The answer is yes.

Almost a dozen clinics across Canada confirmed to CBC News that they are still doing the procedures, with prices quoted as high as $15,000. Ten other clinics that advertised the procedures on their websitecould not be reached for comment.

Health Canada has been in touch with some of the clinics to inquire about their practice, but so far the agency has nottaken any action to stop clinics from doing the autologous procedures. ("Autologous" means the patient's own cells or tissue are being used.)

That's puzzling to University of Minnesota researcher Leigh Turner, who provided his research notes to Health Canada months agoshowing that there were 43clinics in Canada doing the procedures. Turner's findings were published last September.

"It's like Health Canada is saying, 'We know these business aren't complying with Canadian law, and even in our latest document we're confirming that. Nonetheless, we're going to stand here on the sidelines with our hands in our pockets and not doing anything about it.' And that, to me, is the problem," Turner said.

"I don't understand why it's not more of a priority for Health Canada."

Health Canada spokesperson Andr Gagnon told CBC News in an email that the agency is "currently working to bring clinics into compliance with the applicable regulatory framework."

"This will include requesting clinics to stop selling and advertising cell therapy products that do not meet the applicable requirements."

Health Canada did not indicate when it would take that action.

Turner said it's long overdue.

"We're talking about a nationwide phenomenon right now that has received national news coverage," he said. "There's a tremendous amount of empirical information. Health Canada has interacted with people willing to provide more information. Years have ticked by.That's enough time for Health Canada to take meaningful action."

One Alberta clinic announced on its website that it has officially stopped doing the procedures because they fall into a regulatory grey area.

"It was a decision we made and it was our decision alone," said Joe Burnham, regulatory manager at the Capri Clinic in Lacombe, Alta. The clinic performed about 1,500 procedures before deciding to stop in March. But patients are still calling.

"That's 80 per cent of our calls to this day. When are you guys up and running?"

Burnham said his clinic is investigating how to comply with Health Canada's regulations, but it's not yet clearhow that can be done.

"Doctors that are doing procedures aren't drug companies. And the minute you call a procedure a drug, even if you have a regulatory right to, it turns doctors into drug manufacturers. That's the confusion," Burnham said.

Health Canada acknowledged that challenge, telling CBC News: "There is uncertainty surrounding the practical means of meeting federal product safety regulatory requirements for the sale of cell therapies that aren't mass produced, especially once initial clinical trials are completed.

"Health Canada is working to identify and overcome challenges specific to meeting regulatory requirements for the manufacturing and sale of autologous cell therapy products, including those prepared at the bedside."

Despite the claims from clinics that they areextracting stem cells,the clinicsdon't examine the fluid to determine what sorts of cells and other cellular products it contains.

And scientists point out that it is unlikely to contain true stem cells, which are cells that can transform into any tissue in the body. The extract from bone marrow and fat tissue containsanother type of cellsthat wereoriginally called "mesenchymal stem cells."But scientists now say that name is inaccurate and confusing.

In a commentary in Nature, with the title "Clear up this stem cell mess," Turner and some colleagues explained how the science has evolved since the cells in question were first described and named 25 years ago.

"They don't behave like stem cells," Michael Rudnicki, stem cell scientist at the Ottawa Hospital Research Institute, told CBC News last September when we first wrote about the name controversy. "None of the criteria we use to define stem cells are present in this population."

"There are clinical trials exploring their ability to modulate the immune system,but it's not a regenerative phenomenon," said Rudnicki, adding that most researchers in the scientific community have abandoned the term "mesenchymal stem cells" and instead call them "mesenchymal stromal cells."

By continuing to use the term "stem cell" for the fluid that is taken from a patient's bone marrow and fat, there is concern that patients will be misled into believing the therapies are able to regenerate bone and tissue, which has not been proven.

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'Stem cell' therapies offered at private clinics need to ...

FDA Mounts Aggressive Push to Regulate Stem-Cell Clinics …

The Food and Drug Administration has launched a nationwide crackdown on stem-cell clinics, issuing letters of warning and threatening civil actions that could shut them down if they refuse to comply with FDA regulations.

On Wednesday, the FDA sent correspondence to 20 clinics around the country, putting them on notice that they must seek FDA review and approval for their procedures.

Over the past 12 months, the FDA has sent regulatory correspondence to 45 clinics, according to The New York Times, which refers to them as rogue stem-cell clinics.

The regulatory crackdown is a paradigm change for more than 700 stem-cell clinics nationwide that have largely gone unregulated by federal authorities for over a decade.

The procedures being scrutinized include those that concentrate a patients own stem cells and re-inject them into that patientto treat a wide range of painful, debilitating illnesses such as herniated disks, joint pain, reproductive issues, Parkinsons disease, multiple sclerosis, and several others.

The FDA has filed civil actions against two clinics, one in Florida and another in California, in a bid to force them to comply with FDA regulatory regimes applied to major drug manufacturers. That would likely be unsustainable for small practices.

Advocates for regenerative stem-cell medicine charge that Big Pharmas influence is behind the crackdown, suggesting the FDA is being used to clear out potential competitors. They describe stem-cell therapy as a minimally invasive procedure best regulated by local medical boards.

The clinics maintain that because many of the treatments involve harvesting a patients own stem cells known as autologous stem cells and then re-injecting them into trouble spots in that patients own body, they should not be subject to FDA regulation.

Stem cells are undifferentiated, meaning they have the potential to grow into multiple types of bodily tissues. The clinics that use them in treatments maintain they reduce inflammation and promote healing.

Stem cells, they say, have been successfully used to treat thousands of patients, while critics point to cases where patients had adverse reactions including three Florida seniors with macular generation who reportedly suffered severe vision loss after stem-cells were injected into their eyes in a clinical trial, as reported in a March 2017 article in the New England Journal of Medicine.

One factor in the growing controversy: The question of when a procedure involving ones own tissues comes under the purview of federal regulators. Libertarian-minded medical ethicists argue the government should not be empowered to regulate patients decisions about their own medical treatment when it involves materials taken from, and reintroduced into, their own bodies.

Dr. Jeff Singer, a general surgeon in Phoenix who also serves as a senior fellow at the libertarian Cato Institute think tank, tells Newsmax that the FDA refrains from regulation in whats known as same surgery, when a tissue is removed from one part of the body and introduced somewhere else in the same patient. A skin graft would be an example.

But if the tissue is manipulated in some way, it begins to attract the FDAs attention, in part due to the concern the tissue could be somehow contaminated during the handling process.

If its what they call not the same surgery for example you take it and process it and then later on reinsert it into the patient they consider that sort of a creation of a drug, and they claim to have regulatory authority over it, Singer says.

This demarcation is particularly relevant in the case of adipose stem-cell treatments -- that is, stem cells that are derived from fatty deposits in the human body.

The procedure can be performed in just two hours under local anesthesia. An amount of fat approximately equivalent to a stick of butter is removed from the body. Enzymes are added to help the stems cells detach from the fat cells. The fatty material is then spun in a centrifuge to separate out stem cells, which are then collected and re-injected into the treatment areas of the patient.

Singer comments: The FDA considers that sort of like creating a medicine, and therefore it needs to come under their regulatory jurisdiction before its approved thats their position on it.

Singer would like the FDA to limit itself to certifying whether an autologous procedure has been proven to be safe and effective.

For example, he says, if the FDA wanted to say, We havent certified that this process is safe, proceed at your own risk, Im ok with that. But I still want to be able to make my own decision.

Of course patient safety is very important to Singer, but he points out federal regulators are hardly beyond making errors of their own. And he says the principle that the patient, not the government, must ultimately decide his or her own care also must be protected.

As Singer tells Newsmax: If I want to take my own tissue my own, not someone elses prepare it a certain way, and then put it back in my own body, thats as sacred as my right to free speech. From a medical ethics standpoint, its a patient autonomy question.

That the FDA sees things differently has become increasingly evident in recent years. Last December, for example, it issued a news release that warned: Time is running out for firms to come into compliance during our period of enforcement discretion. Well be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.

Perhaps no one in the stem-cell regenerative medicine business has come under greater scrutiny than Dr. Kristin Comella, chief science officer of U.S. Stem Cell, a firm that operates three clinics in South Florida.

Comella has helped train over 700 practitioners in her companys adipose stem-cell methodology, and U.S. Stem Cell has been recognized as a leader in its industry. Comella says the FDAs bid to regulate what patients choose to do with their own tissues is a case of regulatory overreach.

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FDA Mounts Aggressive Push to Regulate Stem-Cell Clinics ...

FDA cracks down on stem cell clinics – CNN

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FDA cracks down on stem cell clinics - CNN

Private clinics peddling of unproven stem cell treatments …

Stem cell science is an area of medical research that continues to offer great promise. But as this weeks paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, are exploiting regulatory gaps to sell so-called stem cell treatments without evidence that what they offer is effective or even safe.

Such unregulated direct-to-consumer advertising typically of cells obtained using liposuction-like methods not only places the health of individuals at risk, but could also undermine the legitimate development of stem cell-based therapies.

Many academic societies and professional medical organisations have raised concerns about these futile and often expensive cell therapies. Despite this, national regulators have typically been slow or ineffective in curtailing them.

As well as tighter regulations here, international regulators such as the World Health Organisation and the International Council on Harmonisation need to move on ensuring patients desperate for cures arent sold treatments with limited efficacy and unknown safety.

Hundreds of stem cell clinics post online claims that they have been able to treat patients suffering from a wide range of conditions. These include osteoarthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. The websites are high on rhetoric of science often using various accreditation, awards and other tokens to imply legitimacy but low on proof that they work.

Rather than producing independently verified results, these clinics rely on patient testimonials or unsubstantiated claims of improvement. In so doing these shonky clinics understate the risks to patient health associated with these unproven stem cell-based interventions.

Properly administered informed consent is often overlooked or ignored, so patients can be misled about the likelihood of success. In addition to heavy financial burdens imposed on patients and their families, there is often an opportunity cost because the time wasted in receiving futile stem cells diverts patients away from proven medicines.

The many recent reports of adverse outcomes demonstrate the risks of receiving unproven cell therapies are not trivial. In the USA three women were blinded following experimental stem cell treatment for macular degeneration (a degenerative eye disease that can cause blindness). One man was rendered a quadriplegic following a stem cell intervention for stroke. And a woman whose family sought treatment for her dementia died in Australia.

Other notorious cases involving the deaths of patients include the German government shutting down the X-Cell Centre and the Italian government closing the Stamina Foundation it had previously supported.

At present, the only recognised stem cell treatments are those utilising blood stem cells isolated from bone marrow, peripheral blood (the cellular components of blood such as red and white blood cells and platelets) or umbilical cord blood.

Hundreds of thousand of lives have been saved over the last half-century in patients with cancers such as leukaemia, lymphoma and multiple myeloma, as well as rare inherited immune and metabolic disorders.

A few types of cancer and autoimmune diseases may also benefit from blood stem cells in the context of chemotherapy. Different stem cells are also successfully used for corneal and skin grafting.

All other applications remain in the preclinical research phase or are just starting to be evaluated in clinical trials.

Further reading: Yes theres hope, but treating spinal injuries with stem cells is not a reality yet

Often dismissed by for-profit clinics as red tape hampering progress, the rigour of clinical trials allows for the collection of impartial evidence. Such information is usually required before a new drug or medical device is released into the marketplace. Unfortunately, in the case of for-profit stem cell clinics, their marketing has gazumped the scientific evidence.

Action is required on many fronts. Regulators at both an international and national level need to tackle regulatory loopholes and challenge unfounded marketing claims of businesses selling unproven stem cell interventions.

Researchers need to more clearly communicate their findings and the necessary next steps to responsibly take their science from the laboratory to the clinic. And they should acknowledge that this will take time.

Patients and their loved ones must be encouraged to seek advice from a trained reputable health care professional, someone who knows their medical history. They should think twice if someone is offering a treatment outside standards of practice.

The stakes are too high not to have these difficult conversations. If a stem cell treatment sounds too good to be true, it probably is.

For more information on recognised stem cell treatments visit the National Stem Cell Foundation of Australia and Stem Cells Australia, Choice Australia, EuroStemCell, International Society for Stem Cell Research, and International Society for Cellular Therapy.

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Private clinics peddling of unproven stem cell treatments ...

Stem cell clinics make big claims but offer little …

If someone says they have a success rate of close to 100 percent in treating a major health problem but offer little evidence to back that up, you might be excused for being more than a tad skeptical. And a new study says you would be right.

The health problem in question is osteoarthritis (OA) of the knee, something that affects almost 10 million Americans. Its caused by the wearing down of the protective cartilage in the knee. That cartilage acts as a kind of shock absorber, so when its gone you have bone rubbing against bone. Thats not just painful but also debilitating, making it hard to lead an active life.

There is a lot of research taking place including a clinical trial that CIRM is funding that focuses on using stem cells to create new cartilage, but so far nothing has been approved by the US Food and Drug Administration for wider use. The reason for that is simple. No approach has yet proven it is both safe and effective.

No evidence? No worries

But that doesnt stop many clinics around the US, and around the world, from claiming they have treatments that work and charging patients a hefty sum to get them.

In a study presented at the Annual Meeting of the American Academy of Orthopaedic Surgeons, researchers contacted 317 clinics in the US that directly market stem cell therapies to consumers. They asked the clinics for information on the cost of the procedure and their success rate.

Only 36 clinics responded with information about success rates.

None offered any evidence based on a clinical trial that supported those claims, and there was no connection between how much they charged and how successful they claimed to be.

In a news release about the study which appears in the Journal of Knee Surgery George Muschler, one of the lead authors, said that orthopedic surgeons have a duty to give patients the best information available about all treatment options.

Recent systematic reviews of cellular therapies for the treatment of knee OA (over 400 papers screened) have found poor levels of evidence for the efficacy of these treatments to date. Current evidence does not justify the rapid rate of growth for these therapies.

Nicolas Piuzzi, the other lead author on the study, says if the evidence doesnt justify the growth in the number of clinics offering these therapies, it certainly doesnt justify the prices they charge.

The claim of stem cell therapy carries a high level of expectations for the potential benefits, but research is still many years away from providing clear evidence of effective treatment to patients. As clinicians and researchers, we have ethical, scientific, legal and regulatory concerns. Patients need to be aware of the status of research within the field. If they receive information from anyone offering a treatment claim of an 80 to 100 percent successful recovery, they should be concerned in observance of published peer-reviewed evidence.

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Stem cell clinics make big claims but offer little ...

UCLA UCI Alpha Stem Cell Clinic | UCLA Broad Stem Cell Center

...part of the CIRM Alpha Stem Cell Clinic Network

The UCLA-UCI Alpha Stem Cell Clinic (ASCC) accelerates the implementation of clinical trials and delivery of stem cell therapies by providing world-class, state-of-the-art infrastructure to support clinical research.

The UCLA-UCI ASCC is a first-of-its-kind collaboration between the University of California, Los Angeles, Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research and the University of California, Irvine Sue & Bill Gross Stem Cell Research Center. It is one of five clinics (alongsideCity of Hope, UC Davis, UC San Diego, and UC San Francisco) funded through an $8M grant from theCalifornia Institute for Regenerative Medicine (CIRM),the states stem cell agency. These five Alpha Clinics comprise the CIRM Alpha Stem Cell Clinics Network.

For more information onclinical trials at the UCLA-UCI ASCC that are active and recruiting, please visit the current clinical trials page. The 'detail' option provides specific information for each trial, including a link to each trial' page (via the NCT number). is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

For a complete list of clinical trials across the CIRM Alpha Stem Cell Clinics Network, please visitCIRM's ASCC clinical trials page.

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UCLA UCI Alpha Stem Cell Clinic | UCLA Broad Stem Cell Center

Stem cell clinics sued | Regenerative Medicine Foundation

Columnist Mitchell Hiltzik savaged the La Jolla-based StemGenix Medical Center The stem cell therapies offered by La Jolla clinic arent FDA approved, may not work- and cost $15,000 reads the title of his pieceon the LA Times. StemGenix is the subject of a federal class-action lawsuit.

Hiltzik calls for the FDA and state medical boards to act now, stating that the clinics are endangering their customers health and draining their pocketbooks for quack remedies, shut them down.

Its not that easy.

Cell therapies in clinical practice are expanding worldwide, at a pace difficult to measure. Its wishful thinking to imagine a regulatory police force shutting down all the bottom feeders and rip-off clinic peddling false claims.

Patientsare eager, if not desperate, to undertake medical treatments to alleviate their debilitating medical conditions- especially where drugs and surgeries have failed them.

Medical doctors want to incorporate into their practices legitimate cell therapies. Not only are they answering consumer demand. Broadening anecdotal evidence shows positive results. It the practice of medicine, unconstrained by reimbursement paperwork, meaning the patient pays up front.

In the meantime, some in industry see regenerative medicine as a negative disruptive force- potentially impacting their companys bottom lines. After all, if an autologous cell therapy alleviates the pain, who will buy the drug?

Moreover, numerous stakeholders lay claim to the brands stem cells and regenerative medicine. Lofty scientific organizations such as the International Society for Stem Cell Research (ISSCR) should be uncomfortable about clinic that brands its PRP protocols as a stem cell treatment. Theres lot of confusion.

Now, into this muddled landscape, come the lawsuits. A good lawsuit has always been a deterrent to bad behavior.

In the StemGenix case, the plaintiffs are three former patients, two with diabetes and one with lupus. There is no allegation of medical malpractice. Plaintiffs counsel shrewdly deploys a smack-down of claims citing California consumer protection laws, false advertising, violations against human experimentation, fraud, financial elder abuse and the crown jewel- a violation of the Racketeer Influenced and Corrupt Organizations Act (RICO), the federal law designed to combat organized crime in the United States- but wielded in civil lawsuits where the allegedly corrupt enterprise encompasses interstate commerce.

That lawsuit, and the monumental publicity surrounding the recently settled Florida case, where a patient was blinded by an alleged stem cell treatment, suggest that the legal floodgates are now open. It will take an extremely well capitalized clinic to withstand damage claims, litigation costs including attorney fees and a bucket full of bad publicity.

Into the breach, communities of professionals such as the American Academy of Regenerative Medicine (AARM) and the International Federation for Adipose Therapeutics and Science (iFats) are now advancing agendas committed to evidence-based medicine, codes of ethics, standards and educational programs to ensure medical practitioners have the proper skills.

The field really could benefit from a universal cell therapy registry where results can be openly shared. In the United States, there are models of funded registries for organ transplant and cell transplantation. Joining the registry could serve as a seal of approval for those sharing outcomes, reflecting transparency and a commitment to the field.

In the meantime, for the bad clinics, one negative clinical outcome, a single disgruntled customer, can sink their ship. The lawyers know a good thing when they see it. They are eagerly sharpening their quills.

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Stem cell clinics sued | Regenerative Medicine Foundation

Patients fleeced by overseas stem cell clinics? Now it …

Alta Charo, Warren P. Knowles professor of law and bioethics at the University of Wisconsin-Madison, is pictured in July 2013.(Photo: Jeff Miller, University of Wisconsin-Madison)

Three women between the ages of 72 and 88 suffered severe loss of vision after receiving injections of stem cells derived from their own fatty tissue, according to a 2017 paper in The New England Journal of Medicine. All three had paid $5,000 to a stem cell clinic in Sunrise, Florida.

In 2009, a Los Angeles woman in her late 60s had to have small chunks of bone removed from the tissue around her eye, after undergoing a new face-lift procedure that included an injection of stem cells, Scientific American reported.

The cells, obtained from her own fat, included mesenchymal stem cells thathelp form skeletal tissue, including bone and cartilage.

A decade ago, U.S. scientists worried about Americans flying thousands of miles and spending thousands of dollars only to get fleeced by stem cell clinics in the regulatory Wild West of countries like China, India, Mexico and Thailand.

Now it happens here.

RELATED: 20 years after the growth of human embryonic stem cells at UW, science faces new frontiers

Leigh Turner, an associate professor for bioethics at the University of Minnesota, found 716 stem cell clinics in the U.S and published a paper on the phenomenon in the journal Perspectives in Biology and Medicine.

Turner found many of the clinics claimed to use stem cells taken from the patients own fat; others said they use blood-forming stem cells obtained from bone marrow. The latter have been used for years to treat some cancers, mostly leukemia and lymphoma.

Turner discovered, however, that stem cell clinics are promoting their cells as treatment for a wide variety of illnesses, including orthopedic conditions, pain relief, neurological disorders, immunological diseases, cardiovascular diseases, kidney diseases, respiratory diseases, Alzheimers, aging, dental problems, vision loss, hearing loss and even hair loss.

The long list of applications for one treatment, experts say, is a tip-off that the claims are dubious.

Its extraordinarily unlikely that a single product is going to have a positive effect on a whole series of diseases, saidAlta Charo, a University of Wisconsin-Madisonprofessor of law and bioethics.

In his paper, Turner said that the FDA, FBI, the Federal Trade Commission and state medical boards all have powers to regulate various aspects of the burgeoning stem cell business.

However the appearance of a well-regulated and strictly overseen marketplace for stem cell products is misleading, Turner wrote. Many U.S. businesses currently advertising stem cell treatments appear to operate in violation of federal regulations because they lack FDA approval for products that require premarket authorization.

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There have been some enforcement actions. In 2017, FDA announced a crackdown aimed at unscrupulous actors in the stem cell business. Earlier this year the agency filed complaints seeking permanent injunctions against two stem cell firms: U.S. Stem Cell Clinic LLCof Sunrise, Florida, and California Stem Cell Treatment CenterInc.of Rancho Mirage, California.

John Gurdon, the Nobel Prize-winning British scientist, said by email that clinics using unproven treatments coulddamage public confidence in stem cell research.

I believe all medical treatments should be conducted based on sufficient scientific evidence, said Gurdon, who shared the 2012 Nobel Prize in Physiology or Medicine with Japanese stem cell scientist Shinya Yamanaka. Unproven treatments can, not only impose huge physical and financial risks on patients, but also lose the credibility of stem cell research. Our first priority should be to ensure patients safety as much as we can.

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Patients fleeced by overseas stem cell clinics? Now it ...

Stem Cell Clinics – eureka

When is a Stem Cell a Drug?

About a decade ago, stem cell clinics began popping up offering unapproved treatments for all kinds of debilitating and incurable diseases using a patients own fat stem cells.

There are now at least170 such clinics just in the US; many plastic surgeons doing liposuction have gotten on board. Stem cell clinics are even more popular outside the US, where they are part of the booming medical tourism industry. People travel all over the world for these treatments. In these cases the source of the cells and types of handling are not always clearly defined, making these treatments a safety concern.

The stem cell product generation involves collection of adipose tissue through liposuction, and isolation of the adipose stem cells with collagenase or other enzymes to create a stromal vascular fraction (SVF). This SVF is sometimes referred to as The Soup because of the lack of defined characteristics. The isolated product, which includes some stem cells, are then injected back into regions of the body from which the cells were not derived, which are referred to as non-homologous sites. The site of delivery depends on what condition is being treated but most of the potential administration sites (e.g., joints, muscles, circulatory system, central nervous system) are not homologous to the tissue of origin, the adipose tissue.

Fuzzy Guidelines

Some companies claim their treatments are approved by the US Food and Drug Administration (FDA), and tout cures for many incurable diseases and conditions, including Parkinsons disease, multiple sclerosis, autism, inflammation, all types of cancers and aging. But news reports have characterized the treatments as the modern-day version of snake oil, and stem cell organizations such as theCalifornia Institute for Regenerative Medicineand theInternational Society for Stem Cell Researchalong with the US National Institutes of Health consider many of these clinics dubious and have issued safety warnings to educate the public.The FDA has cautioned consumersto make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.

How can the use of a patients own cells be potentially dangerous? Some of the safety concerns arise from the extent of the manipulation and possible expansion of the cells outside the body. There are also concerns about the quality controls incorporated in the process, the characterization of the mixture, and complications from the administration back to the patient and the administration site.

It is very possible that some of these SVF treatments, especially for tissue pain and minor inflammation, have some level of therapeutic effect by facilitating tissue repair through release of trophic factors and/or induction of repair/regeneration pathways. However, the exact mechanisms are unknown and it is hard to evaluate the record of success of these therapies because stem cell clinics rarely publish data or findings.

Moreover, the FDA guidelines, until recently, were considered ambiguous concerning the classification and use of these autologous therapies. In the US, cell therapies are, legally, considered both biologics and drugs. They fall under the purview of theFood, Drug and Cosmetic Actbecause they mitigate, treat and prevent disease, but they also fall under the Public Health Service Act, sections351and361specifically, because they convey infectious disease.

Category 361 products are self-derived (autologous), minimally manipulated and used in a homologous manner, and do not need an Investigational New Drug (IND) approval, just an Institutional Review Board (IRB), a site registration and local (not FDA) oversight. Category 351 products are those that are more than minimally manipulated or ones that are used in a non-homologous manner. Marketed drug products fall into this 351 category. They require the whole drug development package (an IND, preclinical safety studies, clinical trials and marketing approval) before they can be prescribed to patients.

Not surprisingly, there has been much confusion over the product classification and definitions of these adipose-derived therapies, particularly over the interpretation of the phrases more than minimally manipulated and non-homologous use.

Minimizing Confusion

A year ago, in an effort to minimize interpretations from previous guidance, the FDA released two draft guidance:Minimal Manipulation of Human Cells, Tissues, And Cellular and Tissue-Based ProductsandHuman Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations. Both further define minimal manipulation and homologous use and provide many clear examples, some specifically addressing SVF.

In order to consider a cell product minimally manipulated, the processing must be shown not to alter the relevant characteristics or physical state of the tissue. For example, if the original characteristic of adipose tissue is to provide cushioning and support to tissues and organs, insulation, and energy storage capacity, then isolating just the adipose stem cells and removing the extracellular matrix that contributes to the tissues function would be considered more than minimally manipulated.

In order to meet the requirements for homologous use the cell product must be used in a tissue that performs the same basic function as the tissue of origin. For example, adipose tissue does not function in bone and joints and use of adipose tissue to treat bone and joint disease would be generally considered non-homologous use. Ultimately, these guidance provide more description for more-than-minimally manipulated, adipose-derived products and clearly state their non-homologous use meets the definition of a marketed drug product.

The intent of the guidance is to educate and provide clinics and doctors with proposed rules to self-correct and reduce the need for enforcement action once these guidelines are approved.

The Preclinical Process

As a result of these clarifying guidance documents, there are now many stem cell companies working through the process of obtaining regulatory approval for their autologous adipose-derived stem cell therapies. This approval will require product characterization and preclinical safety assessments similar to the expectations of a small-molecule or a biologic drug, which may includein vitroandin vivotesting.

The process can be relatively straight-forward and short-term, but ultimately the extent of testing depends on the cell product source, ex vivo manipulations, and use with other products and therapeutic indication. Navigating this preclinical process requires scientists that are familiar with the intricacies of the regulatory expectations, implementation of the testing requirements and performance of the assessments within the regulatory framework.

Assessing Risks

In this budding field of stem cell therapies, there is a lot of promise and still a lot of unknowns. Even with the most stringent and detailed characterization of the cell product and understanding of mechanisms of action, adverse interactions could occur. That is why these products are assessed with a tiered, risk-based approach designed by the FDA to provide the appropriate level of oversight to protect public health.

One case detailed last year inScientific Americandescribed the unintended consequences of not understanding altered cell characteristics of an isolated cell product and potential adverse interactions from chemical alterations. During a cosmetic treatment in 2009, a woman received some of her own adipose-derived stem cells along with some dermal filler to reduce the wrinkles around her eyes. The dermal filler compoundcalcium hydroxylapatiteis the same compound that stem cell researchers use to drive the undifferentiated stem cells down the bone pathway. In this case, the dermal filler differentiated the stem cells to bone and the patient ended up with bone fragments in the tissues surrounding her eyes, which had to be removed surgically.

This treatment met the requirements of a Category 361 product in that it was minimally manipulated and for autologous homologous use UNTIL it was combined with another product. This (thankfully not life-threatening) example of how stem cell treatments can go awry without proper understanding of product and potential interactions support the need for more safety-based oversight of these novel products.

Despite clarifications to the regulatory guidance and reports of adverse reactions in patients with SVF products, the battle rages on with some stem cell clinics. Physicians and stakeholders involved with autologous stem cell clinics are continuing to challenge the non-homologous use issue, claiming they are not creating drugs and that they are using approved materials. And these clinics continue to practice what they term transformative medicine.

In the end, we must have a better understanding of the cells, their activity and interactions before they are administered to humans. Otherwise, we could be creating more health problems for patients already seeking therapies for untreated conditions.

How to cite:

Jackman, Shawna. Stem Cell Clinics. Eureka blog. Nov 16, 2015. Available:

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Stem Cell Clinics - eureka

Mayo Clinic finds surprising results on first-ever test of …

JACKSONVILLE, Fla. Researchers at Mayo Clinics campus in Florida have conducted the worlds first prospective, blinded and placebo-controlled clinical study to test the benefit of using bone marrow stem cells, a regenerative medicine therapy, to reduce arthritic pain and disability in knees.

The researchers say such testing is needed because there are at least 600 stem cell clinics in the U.S. offering one form of stem cell therapy or another to an estimated 100,000-plus patients, who pay thousands of dollars, out of pocket, for the treatment, which has not undergone demanding clinical study.

The findings in The American Journal of Sports Medicine include an anomalous finding patients not only had a dramatic improvement in the knee that received stem cells, but also in their other knee, which also had painful arthritis but received only a saline control injection. Each of the 25 patients enrolled in the study had two bad knees, but did not know which knee received the stem cells.

Given that the stem cell-treated knee was no better than the control-treated knee both were significantly better than before the study began the researchers say the stem cells effectiveness remains somewhat uninterpretable. They are only able to conclude the procedure is safe to undergo as an option for knee pain, but they cannot yet recommend it for routine arthritis care.

Our findings can be interpreted in ways that we now need to test one of which is that bone marrow stem cell injection in one ailing knee can relieve pain in both affected knees in a systemic or whole-body fashion, says the studys lead author, Shane Shapiro, M.D., a Mayo Clinic orthopedic physician.

Journalists, sound bites with Dr. Shane Shapiroare available in the downloads below.

MEDIA CONTACT: Kevin Punsky, Mayo Clinic Public Affairs, 904-953-0746,

One hypothesis is that the stem cells we tested can home to areas of injury where they are needed, which makes sense, given that stem cells injected intravenously in cancer treatments end up in the patients bone marrow where they need to go, he says. This is just a theory that can explain our results, so it needs further testing.

Another explanation is that merely injecting any substance into a knee offered relief from pain.

That could be, but both this idea and the notion that a placebo effect could be involved would be surprising, given that some patients are still doing very well years after their study treatment ended, says Dr. Shapiro.

He adds that these findings are important because while use of a patients own stem cells for regenerative therapy is extraordinarily popular, the treatments may be untested and are often poorly regulated.

Stem cell clinics often offer expensive treatments for conditions that range from multiple sclerosis, lung and heart disease, to cosmetic treatments, such as facelifts. None of these techniques have been studied because clinics maintain that use of a patients own cells is not a drug.

But, depending on how they are processed and used, stem cells can, in fact, be regulated by the U.S. Food and Drug Administration as biological products or drugs requiring rigorous safety and efficacy approval processes. In early September, the FDA held scientific meetings to clarify how to regulate such practices.

Mayo Clinic researchers developed their study with FDA approval.

We feel that if we are going to offer any stem cell procedures to our patients, the science needs to be worked out, Dr. Shapiro says.

The study was conducted in Mayos Human Cell Therapy Lab. Researchers extracted 60 to 90 milliliters of bone marrow from each patient, then filtered it, removed all blood cells, and concentrated it down to 4 to 5 milliliters. The solution, which contained tens of thousands of stem cells, was injected into a patients knee using ultrasound-guided imagery.

We actually counted all of the stem cells with markers that are accepted by the FDA, and we made sure they would be able to survive inside the patient, Dr. Shapiro says. Counting is expensive. Most clinics just draw the cells from bone marrow or fat and inject them back into the patient without checking for stem cells, hoping that patients get better, he says.

Dr. Shapiro and his colleagues are currently designing new studies that will test whether the stem cells home to distant areas of injuries, as well as exploring other implications suggested in their findings.

Study investigators include Mayo Clinic in Florida senior author Mary L. OConnor, M.D., Shari E. Kazmerchak, Michael G. Heckman, and Abba C. Zubair, M.D., Ph.D. Dr. OConnor is now at Yale University.

Funding for this study was from Mayo Clinics Center for Regenerative Medicine.


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