Stem cell cultures growing in multi well sample tray.
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Macular degeneration is the most common cause of vision loss among the elderly. But for some people with the disease, a shot of stem cells to the peeper was all they needed to see again . For others, treatment left them permanently blind . What gives? Stem cell treatments like the one described abovehappening every day in 600 clinics across the USare not approved by the FDA, and in fact have never been tested in a clinical trial.
Eyes arent the only organ getting stabbed full of stem cells. Around the country, more doctors are marketing the therapy to treat everything from diabetes to asthma to erectile dysfunction. The procedure usually involves sucking out some of a patient's fat tissue with a liposuction needle, isolating their stem cells, and reinjecting them back into the place in their body that needs most healing. But because these are living tissues unique to every individual, results may vary. Advocates of the therapy say thats just the cost of doing cutting-edge medicine. Except, any proof they have that it is effective comes from data collected on patients who pay thousands of dollars for the treatment. Usually people pay money for medicine after theres proof it works. In the last few years, some of these stem cell clinicians have begun posting large-scale studies on a government-run website called ClinicalTrials.gov, even though they're often not up to medical research standards or even in compliance with federal regulations. This allows them to masquerade their pay-to-participate studies as legit science.
According to a paper published today by the University of Minnesota, US companies have successfully registered 18 patient-sponsored stem cell studies on that publicly funded website. Only 7 of them disclose that patients pay their own way. None of them list the costs, which can range from $5,000 to $15,000 a treatment, outright. And none of them are actual clinical trials in the randomized, blinded, gold-standard sense of the phrase. Instead, theyre observational studies, based mostly on quality of life questionnaires that ask if youve had any adverse reactions to the procedure.
Leigh Turner, the bioethicist who penned todays perspective and who has become somewhat of a watchdog in the ballooning stem cell clinic industry, says this amounts to hijacking a public good and repurposing it into a free marketing tool. They dont have to pay for ads on television, people just come to them because its this trusted national resource, he says. Its all meant to suggest a seal of approval from the federal government. And thats whats so dangerously misleading, because it doesnt mean that all. It just means someone filled out a form and pressed a button.
Following the passing of the Food and Drug Administration Modernization Act of 1997, the National Library of Medicine established ClinicalTrials.gov to serve as a source of information about publicly and privately supported clinical trials for patients, their families and caregivers, doctors and nurses, and the public. But the NIH doesnt independently verify the scientific validity of any trials posted to the site beyond a limited quality control review. That doesnt really include things like sound study design, compliance with current regulations, or ethical guidelines. In fact, the process is largely automated, and relies almost entirely on the honor system.
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NIH said in a statement that it is continuing to evaluate ways to improve its outreach to make sure that trial participants understand potential risks and benefits. That included adding a prominent disclaimer on the ClinicalTrials.gov homepage in March 2017, stating: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study.
But that hasnt stopped stem cell therapy slingers from touting their clinical bonafides. Cell Surgical Network, an umbrella organization for more than 50 clinics that market the treatment directly to consumers, first registered on ClinicalTrials.gov in October of 2013. At the time, the organization put out a press release noting that the NIH had registered its approved safety study, and that it was now cleared to enroll 3,000 people to study the adverse effects of stem cell treatments on arthritis, cardiomyopathy, Parkinsons, ALS, and a host of other inflammatory and neurological diseases. The ClinicalTrials.gov listing of this study does not mention that research subjects are charged an average of $6000 to participate.
Elliot Lander, a urologist and co-founder of Cell Surgical Network says those costs are necessary because stem cell therapies dont make money like pharmaceuticals dothey can't be packaged up and mass-produced. Which means pharma companies and research institutions arent interested in footing the bill for clinical trials. And he says that while it might be worth noting the costs upfront, the NIH doesnt have a mandatory policy about including fees. Stem cell treatments have no business model, he says. So its left to physicians like myself to do the right thing by my patients, and get them regenerative medicine now, not 10-15 years from now. People dont need to be protected by Leigh Turner, they can do their own due diligence.
So far, at least 6,000 people have followed their due diligence to a treatment at one of Cell Surgical Networks clinics. The network keeps a database of all its patients and their outcomes, hoping for the day when the FDA decides to go from merely ignoring the proliferation of un-approved treatments to giving them a green light based on post-market data (a regulatory middle path floated by advocates like Lander.) In the meantime though, Cell Surgical Network is working with the FDA on an application for a real clinical trial, limited to just knee pain treatmentsthat will even include a randomized placebo. Its going to take us years and a few million dollars, says Lander. The walls are really high for this kind of thing. As they should be.
The rest is here:
At ClinicalTrials.Gov, Untested Stem Cell Clinics ...
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