MedicalResearch.com Interview with:
Dr. Paul J. Hauptman, MD
Professor of Internal Medicine
Division of Cardiology
Assistant Dean, Clinical and Translational Research
Saint Louis University School of Medicine
St. Louis MO 63110-0250
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: A publication in 2016 by Leigh Turner from the University of Minnesota in 2016 shed light on the proliferation of stem cell centers or “businesses” that offer non FDA approved treatments, described as “stem cell therapy” for a variety of conditions. We opted to evaluate sites that claimed to treat heart failure. We collected data on type of infusion, need for a medical evaluation, board certification status of the center physician, cost and other factors. Self reported patient volumes were very variable. Most centers/businesses claimed to use autologous stem cells; a number offered ancillary treatment (i.e. vitamin infusions and hyperbaric oxygen); only one appeared to have a board-certified cardiologist involved. The costs were high for single infusions (mean price of $7694, SD 2737 for autologous cells; slightly less for allogeneic cells). Efficacy claims made during telephone calls with the centers were highly positive.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: As we wrote in the text: “Given the prognosis of advanced heart failure and relatively limited options, clinicians need to be aware that patients may seek out this option and thereby may expose themselves to uncertain medical risks at considerable financial and transactional cost.” Patients need to understand that these procedures are unproven.
Any patient with heart failure interested in stem cell therapy should seek out participation in a formal clinical trial, in which the conditions are controlled, the FDA monitors and safety is tightly scrutinized.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We believe that there are regulatory and policy implications. Leigh Turner recently pointed out that some entries on www.clinicaltrials.gov may include stem cell trials that are not trials, but rather marketing ploys designed to attract business. The question about future research is therefore complex; it may be reasonable to attempt to evaluate outcomes at these centers but we do not know if these data are rigorously collected or accurate or accessible. Greater scrutiny from the FDA is likely to follow.
No relevant disclosures.
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Goff ZD, Kichura AB, Chibnall JT, Hauptman PJ. A Survey of Unregulated Direct-to-Consumer Treatment Centers Providing Stem Cells for Patients With Heart Failure. JAMA Intern Med. Published online July 24, 2017. doi:10.1001/jamainternmed.2017.2988
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