Regenexx gets warning letter from FDA

NEW YORK Colorado-based Regenerative Sciences has received a warning letter from the Food and Drug Administration concerning its biologic product Regenexx, which the company claims can regenerate bone and cartilage, but does not have FDA approval.

The company takes a person’s own mesenchymal stem cells and blood growth factors, grows them in a lab and then reinserts them into the patient’s body.

The FDA considers them drugs because the company intends them for use in diagnosis, cure, mitigation, treatment or prevention of disease, while also offering personal testimonials from patients on its Web site.