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Stem Cell Clinics Found Marketing in ClinicalTrials.gov

Stem cell clinic map

Map of continental U.S. with locations of stem cell clinics. Blue stars indicate hot-spot concentrations. Click on image to view full size. (Leigh Turner and Paul Knoepfler)

20 July 2017. A review of entries in  the U.S. government’s clinical trial registry shows commercial stem cell clinics are using the respected database to promote their services. The findings were revealed in a perspective article appearing in yesterday’s issue of the journal Regenerative Medicine (free registration required).

The article, authored by bioethics professor Leigh Turner at University of Minnesota in Minneapolis, tells how for-profit clinics marketing stem cell therapies for diseases such as diabetes and osteoarthritis register their services on ClinicalTrials.gov, a U.S. government listing of clinical studies. ClinicalTrials.gov is offered by National Institutes of Health as a service for patients, physicians, and researchers, and perhaps the leading authoritative database for current and past clinical studies.

As reported by Science & Enterprise in July 2016, Turner and stem cell researcher Paul Knoepfler at University of California in Davis found nearly 600 clinics in the U.S. claiming to offer stem cell treatments, many having dubious scientific or medical validity. Their analysis shows the clinics often provide treatments for orthopedic and pain disorders, but also for anti-aging and cosmetic applications, including face lifts and breast augmentation, as well as more serious conditions such as spinal cord injuries, and immunological, cardiac, pulmonary, vision, and urological diseases.

Turner says some of these clinics list their services on ClinicalTrials.gov under the guise of clinical studies, using terms such as “patient-sponsored” or “patient-funded” to indicate that people need to pay for participation. Legitimate clinical trials actively recruit participants, with taking part in the studies made free of charge. Individuals participating in clinical trials often need to pay for their own travel and accommodations to the trial sites.

His search through ClinicalTrials.gov uncovered 7 entries of patient-sponsored trials at 2 clinics in Florida and Texas using autologous, or a patient’s own, stem cells to treat type 2 diabetes, osteoarthritis, erectile dysfunction, critical limb ischemia — a serious form of peripheral artery disease — and chronic obstructive pulmonary disease, or COPD.

The author then matched the list of commercial stem cell clinics found in his article published in July 2016 to entries in ClinicalTrials.gov and found 5 of these companies with 11 entries in the registry. Because the trials are conducted by for-profit clinics, Turner suggests participation in the trials requires patients to pay. While the entries do not explicitly say individuals need to pay for participation, one company links its entries to an essay titled, “The Role of Patient Funded Clinical Research in Advancing Medical Care.”

Turner believes including pay-to-participate trials at clinics offering services with dubious medical or scientific value in ClinicalTrials.gov hurts the credibility of the service. Part of the responsibility lies with FDA that does not regulate autologous stem cell treatments, which largely shift cells and tissue from one part of the body to another, such as in cosmetic procedures. However, FDA issued draft guidelines for regulating biologic products such as those based on stem cells in October 2015, suggesting the agency will require its review of treatments going beyond cosmetic procedures.

The author also notes that FDA also does not permit charging patients to take part in clinical trials required for new drug applications, and charging fees to participants in trials can take place only under limited conditions. Turner suggests NIH that offers ClinicalTrials.gov coordinate its listings with FDA to make sure studies charging patients first have clearance from FDA.

Also, says Turner, NIH needs to better police the listings on ClinicalTrials.gov to find pay-to-participate entries. The site now includes a disclaimer, “Listing of a study on this site does not reflect endorsement by the National Institutes of Health.” NIH, adds Turner, needs to go well beyond that disclaimer to maintain the registry’s value.

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