On June 25, 2019, the Southern District of Florida issued an injunction on behalf of the Food and Drug Administration (FDA) preventing US Stem Cell Clinic LLC (USSCC) and its parent company US Stem Cell Inc. from manufacturing and distributing certain stem cell treatments. As the FDA increases its oversight and enforcement of stem cell treatments, this decision appears to affirm the agency’s position that certain stem cell products should be regulated as drugs and biological products – a conclusion that has been refuted by stem cell treatment manufacturers.
USSCC used a mini-liposuction procedure to recover adipose (fat) tissue from donors, processed the tissue to obtain specific cellular components, and then implanted those cellular components back into the donor for the purported treatment of a variety of conditions and diseases including Parkinson’s disease, ALS, COPD, heart disease and pulmonary fibrosis.
USSCC argued that the stem cells derived from this procedure fell within the practice of medicine and beyond FDA’s jurisdiction. It argued that the resulting product was nothing more than the patient’s own cells, taken out of their body, isolated, and then put back into their body.
However, the FDA determined, and the Court agreed, that USSCC’s stem cell products were illegal, unapproved new drugs because:
- USSCC made unsubstantiated claims about the product’s potential to treat or cure serious diseases
- The tissue went through a multi-step manufacturing process and therefore was more than “minimally manipulated” after being extracted from the donor
- The stem cell product did not qualify for the “same surgical procedure” exemption under 21 CFR 1271.15(b)
- The re-implanted stem cells were not intended to perform the same basic functions they performed prior to being extracted
The FDA applies a tiered, risk-based approach to articles containing or consisting of human cells, or cellular or tissue-based products (HCT/Ps). The FDA will not require pre-market approval and generally will not assert regulatory control over stem cell products that are only “minimally manipulated” and that are removed from a patient and transplanted back into the patient during a “single surgical procedure.”
In a Guidance Document, the agency stated that the processing of adipose tissue will be considered more than “minimally manipulated” when the processing alters the original characteristics of the HCT/P. In another Guidance Document, FDA interpreted “same surgical procedure” to require that the HCT/Ps (i) remain in their original form; and (ii) undergo no handling beyond simply “rinsing, cleansing, sizing and shaping.”
USSCC’s stem cell treatment was considered more than minimally manipulated and not eligible for the “single surgical procedure” exemption because USSCC’s processing dramatically transformed the stem cells into something plainly different from their original characteristics and form, and their processing went beyond simply “rinsing, cleansing, sizing and shaping.” As a result, the stem cells were considered analogous to unapproved new drugs.
The FDA is committed to aggressive oversight of stem cell products and the clinics, individuals, and companies involved in the industry. In addition to this injunction, the FDA has sent 46 manufacturers and health care professional regulatory correspondences, including warning letters and untitled letters in just the past year. It is vital for individuals and companies involved with stem cell therapies to understand and comply with FDA’s regulatory requirements. Frier Levitt represents companies and individuals with stem cell compliance issues. Contact Frier Levitt to speak to an attorney.
