"Stem Cell therapy": Galore of Clinics in Florida . Where is FDA?

 A total of 20,135 patients were reported as treated with cellular therapeutics across the Florida clinic sites we surveyed; 2157 of these were treated for “cardiac conditions.” All clinics reported that they employed intravenous administration for cardiac indications. They noted using either adipose (7 clinics) or umbilical-derived (4 clinics) sources, with 3 clinics offering both. The estimated doses administered ranged from 30 million to 1 billion cells per treatment, according to 4 clinics that had the information available. The reported “success rate” ranged from 65 to 85% from the 2 clinics that had these data available. Neither clinic could elaborate on how they defined or measured success. The reported price to patients ranged from $6000 to $20,700 for 7 clinics willing to provide these data. The mean price for therapy utilizing adipose tissue-derived cells was $7742 (6 clinics) while the price for umbilical cord tissue-derived products was $12,162 (4 clinics). The mean price across 7 clinics was $9593, while the median price was $6500. By multiplying the median price by the total number of patients treated for cardiac conditions, we estimate that > 14 million dollars were spent by these patients receiving cell therapy for heart failure or associated cardiac conditions.

Cell harvesting and administration were performed by PAs, MDs, and DOs specializing in surgery, internal medicine, or pain management, with only one clinic reporting presence of a “cardiac specialist” and another clinic reporting presence of a “stem cell scientist.”

Adverse events were reported as none (3 clinics) or described as few (4 clinics): one clinic reported occurrence of flu-like symptoms after cord blood, which was rectified by switching to a Wharton’s jelly product; another clinic simply reported adverse events rates as < 1%; another reported one adverse event related to the injection itself; and one clinic reported 2 cases of “pseudo-sepsis.”

Publications related to their stem cell treatments were reported by 3 of 8 clinics. One clinic reported having a previous partnership with an academic institution, one was “working on” a future academic partnership, and a third had a doctor who is a clinical professor at a local institution. All clinics claimed to either be “in compliance” with FDA regulations or “exempt” from FDA regulations entirely. One clinic stated treatment is legal under “right to try,” another said “stem cells are not drugs and therefore are not under FDA regulations,” another cited their compliance “as indicated by only treating diseases with significant clinical evidence,” another said they “follow FDA procedures for sterility and handling of cells,” another specifically cited “compliance via the same surgical procedure exception of 21 CFR 1271,” and 2 others simply said that they were “compliant,” but provided no further explanation.