Dynamic Stem Cell Therapy FDA Warning Letter Investigation

In February 2026, the U.S. Food and Drug Administration sent a warning letter to Dynamic Stem Cell Therapy, a clinic in Henderson, Nevada, regarding their products marketing to the public. The agency’s Center for Biologics Evaluation and Research focuses on an umbilical cord-derived stem cell product that, according to the FDA, the company markets on its website for allogeneic use, meaning cells that come from a donor.

The regulators pointed to specific website statements that raised eyebrows. One section reportedly described stem cells as a treatment for sports injuries such as ligament tears, rotator cuff problems and Achilles tendon ruptures. Another said stem cell therapy has been shown to improve conditions including spinal cord injury, cardiovascular disease and arthritis.

The FDA has made it clear that claims like these show the product is meant to treat disease, which would make it both a drug and a biological product under federal law.

Contact our consumer protection attorneys to learn more about filing a case and seeking damages for the deceptive marketing of stem cell products and making misleading statements about treatments.

Understanding Stem Cell Regulations

The agency says processing turns the harvested materials into an injectable form, which it considers more than minimal manipulation. It also says treating arthritis or heart disease does not match what an umbilical cord does in the donor. The letter adds that no approved biologics license exists for the product. ‍

These are the FDA’s positions, and the company has the right to respond and disagree.

This is not the first FDA letter sent to Dynamic Stem Cell therapy. An April 1, 2020 letter described marketing of adipose and umbilical cord products for a long list of conditions, including COVID-19. Both letters mention exosomes, which the FDA says generally need premarket approval when used to treat or prevent disease.

A warning letter does not amount to a court finding, and neither letter describes an injured patient. The 2026 letter gave the company 15 working days to respond and said further action could include seizure or injunction.

Can you File a Claim Against Dynamic Stem Cell?

The legal basis for a claim depends on what patients may have understood. Patients who paid for treatment after reading website claims may now wonder whether the marketing matched what they received.

If you or a family member received an umbilical cord, stem cell or exosome treatment from Dynamic Stem Cell Therapy, the stem cell fraud lawyers at The Lyon Firm wants to hear from you.

Consumer protection laws in many states let patients seek refunds or damages when advertising is false or misleading, and filing deadlines vary by state. Attorney Joseph Lyon has represented consumers in class actions and mass torts across all fifty states.

Gather website screenshots and treatment records, then call (513) 381-2333 for a free, confidential case review.