Stem cell treatments that are FDA-approved or being studied under an Investigational New Drug Application (IND) are considered legal and have undergone rigorous testing for safety and efficacy. However, many stem cell treatments offered by clinics worldwide are unproven and unregulated, posing significant safety risks to patients. The FDA has taken action against unapproved stem cell products and clinics offering such treatments. The scientific literature supports the potential of stem cells in treating a wide range of conditions, but also emphasizes the need for further research to establish their safety and effectiveness.

The FDA has established a division to regulate blood products, known as the Center for Biologics Evaluation and Research. Under regulation 21 CFR 1271.15(b), treatment using a patient’s own blood products is allowed by the FDA. Numerous devices that prepare PRP have been FDA cleared. Cell therapy, if utilizing a patient’s own cells, and if those cells are “minimally manipulated” is also allowed by the FDA. The FDA still considers these treatments to be investigational.