Regenerative Wellness Clinic

Regenerative Wellness Clinic is a medical facility primarily known as a subsidiary or d/b/a of U.S. Stem Cell, Inc. (formerly Bioheart, Inc.), a biotechnology company specializing in autologous cell therapies. The clinic offered regenerative treatments using adipose-derived stromal vascular fraction (SVF) and bone marrow-derived stem cells for a variety of conditions, including orthopedic, neurological, and cardiovascular diseases. It became a focal point of regulatory scrutiny when the FDA filed a permanent injunction in 2019, which was later upheld, prohibiting the clinic from marketing unapproved stem cell products. This legal action followed reports of serious patient injuries, including vision loss, associated with the clinic's procedures. For a biotech analyst, the company serves as a significant example of the regulatory boundaries and enforcement risks within the direct-to-consumer stem cell industry.