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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. 2017;177(9):1387–1388. doi:10.1001/jamainternmed.2017.2988
Stem cell therapy for the treatment of heart failure (HF) is under investigation but not approved by the US Food and Drug Administration (FDA).1 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.
Stem cell centers marketing treatment for HF were identified using a published database.2 We used a standardized script in a telephone survey to ensure consistency in data collection. Several centers had multiple satellite locations; for these, only 1 was contacted. Inquiries included stem cell source, infusion method, treatment number, preprocedural evaluation, follow-up, and price. Representative statements by stem cell center personnel were chronicled. The board certifications of physicians named on center websites were compared against online registries.3,4
Standard descriptive statistics were used (IBM SPSS Statistics for Windows; version 24.0). For centers that provided a range (n = 5), the mean of the minimum and maximum price was calculated. The study was deemed exempt by the Saint Louis University institutional review board.
Of 61 centers listed as offering HF therapy in 2016,2 15 were satellite sites. Seven centers no longer had active websites or had been closed by the FDA; 2 could not be contacted; 2 refused to provide data; 3 did not offer HF treatment despite online claims; 1 did not offer treatment for severe HF; and 1 required advance payment ($250) for telephone consultation.
Half of the remaining 30 centers responding to the survey were located in 3 states (8 in California, 4 in Florida, and 3 in New York). The self-reported number of procedures performed varied widely; 5 claimed more than 100. Medical records were required at only 9 centers, and a cardiologist’s note was requested at 6. None of the sites discussed methodologies used to isolate or identify stem cells; most claimed to use autologous stem cells alone (24 adipose-derived, 1 from bone marrow), 2 treated with allogeneic stem cells (umbilical or placental), and 3 offered multiple sources. Stem cells were delivered intravenously in 29 centers; 1 performed direct coronary infusion. Stem cells were infused on the same day as harvest in all centers offering autologous infusions; 6 offered cell banking. Ancillary treatments (vitamin infusions and hyperbaric oxygen) were offered in 5. Follow-up was required at 2 centers.
The mean (SD) price for a single treatment was $7694 ($2737) for autologous and $6038 ($3145) for allogeneic cells. A discount ($500) was offered at 2 centers if the procedure was paid for in cash; additional procedures were offered for a discounted price (7 centers; mean discount, $3893 [$888]).
From 39 centers with websites advertising HF treatment, 79 physicians were identified: board certified in cardiology (n = 1), board certified in another field (n = 55), and unverified board certification status (n = 13). Ten had no formal medical training but were described as “naturopathic medical doctors.” Characteristic statements recorded during the telephone survey are shown in the Box.
“If you know anyone that can start an IV, a neighbor that is a nurse for example, we can send you the stem cells and that person can administer them to you.”
“The total cost is around $8000, but that can be negotiated, if you come here we can work something out.”
“Generally speaking, everyone [that receives stem cells] gets better.”
“We hope you don't believe your doctor when they tell you there is nothing they can do, you were smart to call us.”
“It takes years to determine the effect or outcome of the procedure.”
“[Adverse effects] are typically good, we had a patient come in for diabetes and treatment caused his bleeding hemorrhoids to stop.”
“Problem areas act as a magnet to stem cells.”
“It is hard for me to know how many cells are actually getting where they need to go.”
“If you have a million dollars to spend we will set you up with weekly infusions.”
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 repair2 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. 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,5 though some monitoring of these businesses does occur.6
The survey was restricted to US sites only; nevertheless, the issue is global.7 Information derived in this study cannot be independently verified; however, the data provided are largely unavailable on websites and are not publicly reported.
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. The implications for regulatory policy are significant.
Corresponding Author: Paul J. Hauptman, MD, Department of Medicine, School of Medicine, St Louis University Hospital, 3635 Vista Ave, 15-DT, Saint Louis, MO 63110 (firstname.lastname@example.org).
Accepted for Publication: May 15, 2017.
Published Online: July 24, 2017. doi:10.1001/jamainternmed.2017.2988
Author Contributions: Drs Goff and Hauptman had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Goff, Kichura, Hauptman.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Goff, Hauptman.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Goff, Chibnall.
Administrative, technical, or material support: Goff, Chibnall, Hauptman.
Study supervision: Hauptman.
Conflict of Interest Disclosures: Dr Hauptman reports consulting for St Jude Medical, Sensible-Medical, Corvia, Array Biopharma, and Relypsa; speaker bureau for Relypsa and Otsuka; and research funding from Alnylam, Relypsa, and the National Heart, Lung and Blood Institute. No other disclosures are reported.
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