Defying the FDA, Doctors in Colorado Offer Stem Cell Therapies for Joint Diseases
March 17, 2010 11:25 AM Subscribe
The FDA has yet to approve stem cell therapies for general use in medicine, but that hasn’t stopped doctors in Colorado from providing them anyway. Background
posted by zarq (50 comments total)
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In 2007, Colorado-based Regenerative Sciences Inc., (RSI) began
", to the public: an adult stem cell transplant that uses injected autologous mesenchymal stem cells
to treat joint injuries and bone damage, as an alternative to traditional surgical techniques. Since then, they claim to have treated 348+ patients with 800+ injections and are reporting high success rates: 89% of their knee patients and 75% of their hip patients showed marked improvement
. (Scroll to: "What is the success rate? How many people respond? What is the cure rate?")
Drug, or Surgical Procedure?
In 2008, the FDA sent RSI an untitled warning letter
, which said the company could not use mesenchymal stem cells as an injectible on humans without a biologics license (BLA) or an investigational new drug application (IND). (See: "Will the FDA kill adult stem cell medicine?"
) More here (followup in first graph of this post)
. The company responded
, claiming Regenexx is a surgical procedure, (even though the cells are lab-cultured and used to treat disease conditions,) and thus not subject to FDA regulation
. A response from the FDA is still pending.