Are Stem Cell Companies Abusing ClinicalTrials.gov? – PLoS Blogs (blog)

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Aug 10 2017

Im often asked about the safety of treatments that purport to inject stem cells into painful body parts. The reputation of stem cells seems to exceed the reach, with companies touting treatments that arent FDA approved or even being tested.

Back in March, an alarming article in the New England Journal of Medicinedescribed three women blinded by stem cell treatments two of the patients reported seeing a reference on the company website to registration at the National Institutes of Healths well-respected ClinicalTrials.gov, and assuming it applied to their treatment. It didnt.

In what is perhaps a modern version of hawking snake oil, companies can indeed register certain clinical trials without breaking any rules but desperate patients might not know that.

There is no doubt that some patients have misinterpreted a studys listing on ClinicalTrials.gov as a stamp of legitimacy, federal review, and compliance. In this way, treatments with no safety or efficacy data, no prior clinical study, and no ongoing clinical trials under FDA review, appear to have federal approval. Such a misunderstanding can lead to disastrous outcomes for patients, said Thomas Albini, MD, of the Bascom Palmer Eye Institute of the University of Miami, who treated the blinded women.

When I wrote about the disaster here at DNA Scienceand atMedscape Medical News, my Medscape editor asked me to take a closer look at criteria for listing investigations at ClinicalTrials.gov. It proved an interesting exercise, but I declined to write an article, fearing lawsuits if I named companies.

ClinicalTrials.gov is where research groups, in academia and pharma/biotech, describe protocols to evaluate the safety and efficacy of new drugs, biologics, and devices, which FDA regulates, typically in randomized, controlled trials. But for an observational study that just follows what happens after a treatment, no such thumbs-up is required; no investigational new drug (IND) designation or investigational device exemption (IDE) need be filed. And that creates a loophole that companies are happily jumping through and luring patients in pain, who may know little about clinical trial design, and perhaps trust too much the companies and the doctors offering these services.

Its easy to see how people are fooled. One company claims that By providing access to registered clinical studies through the NIH, we are providing patients with the ability to choose a stem cell treatment center with the highest standard of care. If the treatment is experimental, how can there even be a standard of care?

MOST STUDIES LEGIT

I love ClinicalTrials.gov its packed with information about all manner of conditions, with contacts and references. I started my investigation by searching for studies that sounded bogus.

I began with a treatment that epitomizes pseudoscience: magnets. But I was fooled. Other than legit uses in medical devices, my magnet search called up as an acronym of sorts for theMothers and Girls Dancing Together Trial, a well-designed study on preventing childhood obesity, with a decent sample size and controls.

I also thought the randomised crossover trial of the acute effects of a deep-fried Mars bar or porridge on the cerebral vasculature was fake, but it turned out to be a medical students project, well done, and published in the Scottish Medical Journal.

But trial NCT02833532, sponsored by a Korean pharmaceutical company, was likely a joke, with the stated purpose of temporary penile enhancement and one of the investigators first name being Dong. Participants must answer the question How do you rate your penile size? Very small/small/normal/big/very big to enroll. Those accepted get to try something made of hyaluronic acid, which is found, coincidentally, in cocks combs.

Searching ClinicalTrials.gov for stem cells returns more than 4,000 entries, so I gave up. Fortunately, Leigh Turner, PhD, associate professor at the Center for Bioethics at the University of Minnesota, wasnt afraid of lawyers and took a more measured, scholarly approach. He recently published the intriguing findings in Regenerative Medicine, where you can find nice tables naming the stem cell companies that use and possibly abuse ClinicalTrials.gov.

AN ACADEMIC INVESTIGATION

Dr. Turner searched ClinicalTrials.gov for stem cells along with patient-sponsored, patient-funded, and self-funded because expecting patients to pay is a red flag. Only a very few real clinical trials charge patients, and those that do must have FDA approval to do so.

He found 7 such pay-as-you-go clinical trials, each enrolling more than 100 people, at the government website, and another 11 in a database of companies that provide direct-to-consumer stem-cell-based treatments. The DTC label indicates that the treatments arent part of a real experimental protocol. One of themhad signed up more than 3,000 gullible people.

The companies that charge patients yet proclaim a ClinicalTrials.gov listing are having their proverbial cake and eating it too borrowing the governmental veneer of a sanctioned clinical trial, while collecting fees. And many health care consumers arent even aware theyre being bamboozled.

Another red flag in a stem cell pitch is an everything-but-the-kitchen-sink list of targets. Stem Cell Network, for example, claims to be able to treat, using stem cells grown from a patients fat, some 28 conditions, including the vague knee problems, and also muscular dystrophy, ankle problems, neuropathy, asthma, and alopecia areata. Also be wary of stem cells derived from one body part like butt fat being injected into another body part such as eyeballs.

Wed like people to protect themselves by going to a reliable website, like ClinicalTrials.gov, to distinguish legitimate from bogus claims of stem cell clinics. But the findings of this paper challenge that advice because this valuable resource, which is designed to promote transparency and to help people find clinical trials, lists unlicensed and unproven stem cell interventions that companies turn into personal marketing platforms. So if you have ALS, MS, Parkinsons disease, a ClinicalTrials.gov listing looks like any other study on the NIH website. Many people think a listing is credible, Dr. Turner told me.

There is an urgent need for careful screening of clinical studies before they are registered with ClinicalTrials.gov, Dr. Turners paper concludes. But in the current climate of a nuclear threat, a health care system in disarray, and possible cuts to the CDC, FDA, and NIH, ramping up scrutiny at ClinicalTrials.gov is unlikely to have priority, if the President even has a clue what it is.

Its not possible to slash, burn, defund, and deregulate at every turn and think that federal agencies are going to improve how they function. But no administration is forever, no budget is forever, deregulatory moments dont last forever, and perhaps problems that are ignored or neglected now will be addressed in the future, with collateral damage along the way while nothing is done, warns Dr. Turner, who lives in Canada. I wonder if he has a spare room.

Those seeking stem cell treatments should check out the International Society for Stem Cell Research (ISSCR) Patient Handbook on Stem Cell Therapiesand stemcells.nih.gov. Alas, much of the media is still somewhat unfamiliar with the biology of stem cells, that they are not cells that can turn into any cell typebut that they self-renew and jettison a new stem cell at every division. Thats what makes them stem cells, not the ability to spawn specialized cells.

So I tell people who ask me if they should have stem cells shot into their aching knees or backs to do so only if they wouldnt object to an abnormal growth cancer forming there.

When it comes to stem cell therapies, its caveat emptor buyer beware!

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Are Stem Cell Companies Abusing ClinicalTrials.gov? - PLoS Blogs (blog)

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