This website is intended to inform and educate medical professionals. It is not intended for patient diagnosis or treatment. It also does not seek to make claims about the effectiveness of stem cells in medical treatment.
Stem cell therapies have great potential in treating a range of chronic conditions. This site serves to inform medical professionals about stem cell regenerative medicine products, the BioGenix stem cell product, and key in vitro, animal model, and clinical research studies that have been carried out to date across medical specialties and health conditions. However, stem cell medicine is an early and evolving field, and clinical studies are still insufficient to determine effectiveness.
While the umbilical cord mesenchymal stem cell product used is produced in an FDA compliant laboratory, stem cells have not been approved by the FDA for treatment effectiveness. The FDA states:
Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.
Patients interested in stem cell therapy in the U.S. are advised to consult a physician about the state of FDA approval for any given product and/or inquire about opportunities to participate in a clinical trial. Patients interested in stem cell therapy outside the U.S. should investigate regulations in the specific country. It is important to be aware that regulations and clinical study requirements vary from country to country.