Stem Cells for Heart Failure: A Survey of Unregulated Direct-to-Consumer Treatment Centers

Introduction: Stem cell therapy for heart failure (HF) is under clinical investigation. Despite lack of FDA approval, stem cell centers (SCCs) in the U.S. are currently promoting this treatment for advanced HF. We obtained data about the procedures provided by these centers, including type, cost and clinical efficacy claims. Methods: Calls were made to SCCs listed in a published U.S. database. A structured script was used that included medical details of a standardized patient inquiring about: stem cell source, infusion method, need for medical records and follow-up, adjunctive therapy and pricing. When centers had multiple satellite locations, only one was contacted. Data were analyzed with standard descriptive statistics (mean ± standard deviation or median). Results: Of 39 unique SCCs advertising HF therapy in 2016, 4 did not respond to repeated calls, 4 did not offer therapy for advanced HF despite online advertisement and 1 required upfront payment for information, resulting in a final sample of 30. Half were located in 3 states (CA = 8, FL = 4, NY = 3). The number of procedures performed varied widely: 4 SCCs had no prior experience with HF, 5 claimed more than 100 procedures. Patient medical records or a cardiologist's note were required at 9 and 6 centers, respectively. Sources of stem cells were autologous in 25 (96% adipose-derived), allogeneic in 2 (umbilical, placental) and both in 3; infusions were intravenous in 29 and by coronary angiography in 1. Ancillary treatments (vitamin infusions and hyperbaric oxygen) were offered in 5. In-clinic follow-up was required at 2 centers. The mean price for a single autologous treatment was $7,694 ± $2,737; the corresponding price for allogeneic cells was $6,038 ± $3,145 (Table 1). Discounts were offered at 7 centers (median $4,000) for repeated treatments. Qualitative efficacy comments (not shown) were universally encouraging and positive. From the original sample of 39 centers, 79 affiliated physicians were identified: board certified in cardiology (n = 1) or another field (n = 55) and unverified board certification status (n = 13). Ten had no formal medical training (described as “naturopathic medical doctors”). Conclusions: Non-FDA approved procedures purported to provide stem cell treatment for HF are offered to patients at considerable financial cost and without rigorous pre-procedural evaluations or post-procedural follow-up. Most participating physicians are not board-certified in cardiology. This practice presents a potential risk to patients with significant implications for regulatory policy.Table 1Selected stem cell center characteristics and pricing.