The National Institute for Arthritis and Musculoskeletal and Skin Diseases will be starting its own transplant center to investigate the potential of bone marrow stem cells for muscle and bone diseases, according to a recent article in Wired News.
The NIH is already investigating embryonic stem cells as well as mesenchymal stem cells (a type of stem cell found in the bone marrow) to see if they can make cartilage and ligaments in laboratory dishes. Wired News reports that damaged joints in race horses are currently being aided through injections of mesenchymal stem cells.
What the article doesn’t mention is that there’s already a company doing something similar in humans, and it just got a letter from the FDA stating that the company’s therapeutic claims violated regulations and asking for a written response of how the company, Regenerative Sciences, will address them. I could not find any other such letter to another stem cell company.
Collecting and re-injecting a patient’s own cells is not regulated by the FDA if those cells are considered minimally manipulated and if providers do not make therapeutic claims that would cause it to be regulated as a drug. The FDA letter summarized the procedure as drawing blood, then isolating and growing mesenchymal stem cells in a lab. It quotes enthusiastic testimonials from website of a Colorado company called Regenerative Sciences.
Matt Fulton, the CEO of the company said that the company is supplying the FDA with additional information. “We are confident that questions will be answered to their satisfaction.” He did not reply to my queries of whether the company would seek formal FDA approval of its product or change the claims on its website.
The website does not describe risks of the procedure. It does state that insurance is unlikely to cover it, but does not explain that it has not been tested in clinical trials. Its claims are modest compared those of websites of other companies that operate out of the United States.
Stem-cell scientists have frequently warned against exaggerated claims that could lead patients to pay tens of thousands of dollars for useless and potentially harmful interventions.
See also
Stem cell researchers face down medical tourism
Patients paying for stem cells probably get bad science
Mesenchymal stem cells are being studied in some clinical trials for heart disease