Big promises? Questionable stem cell therapies marketed to heart failure patients

The U.S. Food and Drug Administration (FDA) is examining potential benefits from stem cell therapies for individuals with heart failure, though it has not approved any. Regardless, more than 500 businesses in the U.S. are marketing the benefits of stem cell therapy for heart failure.

In a research letter published online July 24 in JAMA Internal Medicine, four physicians from the St. Louis University contacted 61 centers offering such therapies, using a standardized script to gather information about treatments, cost and claims of efficacy.

The team—Zackary Goff, MD; Andrew Kichura, MD; John Chibnall, PhD; and Paul Hauptman, MD—reported widely varying results. Key points include:

• Of 79 physicians identified through center websites, one was board certified in cardiology, 55 were board certified in another field and 13 were unverified. Ten had no formal medical training.
• The mean price for one treatment was $7,694 for autologous infusions and $6,038 for allogeneic.
• Seven centers no longer had websites or were closed by the FDA, and two refused to provide data.
• Nine centers required medical records, and six requested a note from a cardiologist.
• No centers described how stem cells were isolated and collected.
• One center required a $250 payment for an initial phone consultation.
• California had the most centers with eight; Florida had four, and New York had three.

Considering such information, the researchers called for increase oversight.

“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,” Goff et al. wrote. “The implications for regulatory policy are significant.”

Read the full letter here.