Disclaimer

This website is intended exclusively for the education and information of licensed medical professionals. It is not designed for patient use and should not be interpreted as medical advice or as a guarantee of treatment outcomes.

Regenerative medicine and related therapies, including mesenchymal stem cells (MSC), MSC-derived exosomes, and natural killer (NK) cell banking, represent areas of active and promising research. However, these fields remain in early stages of clinical development. Current scientific evidence—spanning in vitro studies, animal models, and limited human clinical research—has yet to establish the definitive safety or effectiveness of these therapies for medical treatment.

FreshCell products are manufactured in an FDA-compliant facility, but they are not FDA-approved for the treatment, cure, or prevention of any disease. As the FDA states: “Medical products intended to treat, cure, or prevent diseases generally require FDA approval before marketing. To date, the FDA has not approved any stem cell-based products for clinical use, except for cord blood-derived hematopoietic progenitor cells (blood-forming stem cells) for certain indications.”

Patients in the United States who are considering regenerative therapies should consult their physician about the regulatory status of any product and may also explore participation in approved clinical trials. Individuals outside the United States should carefully review the regulations and clinical trial requirements of their respective countries, as standards vary internationally.