Interesting Story on FDA and Stem Cells from Becker’s Orthopedics
This was from a last month and got stuck in my junk e-mail box, but I couldn’t have said it better myself. Becker’s Orthopedics is a website that comments on current orthopedic and pain management news.Request a Regenexx Appointment
AAPS: FDA Regulations Stymie Stem Cell Therapies for Orthopedics
The Food and Drug Administration has imposed regulations on using stem cell therapies for orthopedic applications despite studies that suggest these therapies are beneficial, according to a news release from the Association of American Physicians and Surgeons.
Surgeons remove the cells from the patient and process them to create a tissue culture. The cells are then injected back into the patient’s knee joint to promote meniscal repair. Primary research shows that patients with osteoarthritis may be able to avoid a total knee replacement with stem cell therapy.
AAPS suggests that 500 deaths from surgical complications could be prevented each year if 10 percent of total knee replacements were averted. Development of these therapies has been stalled by the FDA’s attempt to impose regulations on the treatment. Follow-up data on stem cell therapy shows no higher rate of complications than other injection-based treatments, which are exempt from the FDA’s regulatory framework.
Read the release on regulation of stem cell therapies.