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‘Stem cell centers’ often deliver therapy for HF without preevaluations, follow-up

While stem cell therapy for heart failure is still undergoing investigation by the FDA, a number of clinics are marketing the therapy directly to consumers, but a recent analysis published in JAMA Internal Medicine calls into question their medical standards and practices. Researchers found that patients could be treated with stem cell therapy without undergoing rigorous preprocedural evaluations or postprocedural follow-ups by a clinician who does not specialize in cardiology.

“Stem cell therapy for the treatment of heart failure (HF) is under investigation but not approved by the FDA,” Zackary D. Goff, MD, from the Saint Louis University School of Medicine, and colleagues wrote. “Nevertheless, through direct-to-consumer promotion, ‘stem cell centers’ claim to offer this treatment to patients. We sought to assess the type of treatments, cost, and statements made about efficacy.”

Goff and colleagues searched a published database to identify stem cell centers offering HF treatment (n = 61). The researchers ensured consistency by using a standardized script in a telephone survey. The survey inquired about stem cell source, infusion method, treatment number, preprocedural evaluation, follow-up and price. The mean price was calculated for centers that provided a range (n = 5). They recorded representative statements by stem cell center personnel and compared board certified physicians named on center websites with online registries.

Of the 61 centers included in the study, 15 were satellite sites, seven no longer had active websites or had been shut down by the FDA, two were unable to be contacted, two declined to provide data, three did not provide HF treatment despite claiming to online, one did not treat severe HF and one required an advanced payment of $250 for telephone consultation. Of the remaining 30 centers, 15 were in California, Florida and New York. There was a large variation of the self-reported number of procedures performed, with five claiming more than 100. Nine centers required medical records and six requested a cardiologist’s note. Methodologies used to isolate or identify cells were not discussed at any of the centers and a majority said they used autologous stem cells alone, while two used allogeneic stem cells and three offered multiple sources.

In 29 centers, clinicians delivered stem cells intravenously, while one center conducted coronary infusion. In the centers that offered autologous infusions, the infusion of stem cells was performed on the same day of harvest. Cell banking was offered at six centers and ancillary treatments, such as vitamin infusions and hyperbaric oxygen, were offered in five. Two centers required follow-up.

Data showed that for autologous and allogeneic cells, the mean price for a single treatment was $7,694 and $6,038, respectively. If the procedure was paid in cash, two centers offered a discount of $500 and additional procedures were discounted at seven centers (mean discount, $3,893). Seventy-nine physicians were identified at 39 centers that advertised HF treatment online. Of those, one was board certified in cardiology, 55 were board certified in another field, 13 had an unverified board certification status, 10 did not receive formal medical training, but were described as “naturopathic medical doctors.”

“A recent analysis identified 570 businesses in the United States engaged in direct-to-consumer marketing of stem cell interventions including centers purported to provide stem cells for cardiac repair to patients with HF despite lack of FDA approval. We found that such treatment is delivered without rigorous preprocedural evaluations or postprocedural follow-up. Most physicians were not board certified in cardiology,” Goff and colleagues concluded. “The reasons why these businesses can continue to operate are not clear; in a recent publication, the former FDA commissioner did not address the FDA’s role, though some monitoring of these businesses does occur.”

“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,” they added. “The implications for regulatory policy are significant.”

The medical ethics of this conduct is a complex issue, Paul J. Hauptman, MD, coauthor of the study from the Saint Louis University School of Medicine, told Healio Internal Medicine.

“Some patients may want access to a treatment even if not FDA approved,” he said in an interview. “But we have a system in place to protect patients from unproven and potentially harmful medical interventions. To my knowledge, there is no evidence to suggest that stem cell infusions work in HF — at least not yet. Cell type, infusion system, dose, frequency and durability have not been established.” – by Alaina Tedesco

Disclosure: Goff reports not relevant financial disclosures. Please see full study for complete list of all other author’s disclosures.