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Interesting Story on FDA and Stem Cells from Becker’s Orthopedics

POSTED ON IN Knee Latest News Regulation BY Chris Centeno

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.

FDA regualtions stymie stem cell

AAPS: FDA Regulations Stymie Stem Cell Therapies for Orthopedics

Written by Laura Miller | June 02, 2011


Tags: FDAorthopedicsstem cell

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.



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    About the Author

    Chris Centeno

    Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…

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