FDA's Regulations Stymie Stem Cell Therapies for Orthopedics

[Jeannine]

FDA's Regulations Stymie Stem Cell Therapies for Orthopedics
Written by Laura Miller | June 02, 2011

http://beckersorthopedicandspine.com/orthopedic-spine-device-implant-news/4110-aaps-fdas-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

[barbara]

What the FDA is doing is outrageous. They are endangering lives by continuing to not allow adult stem cell treatments in the U.S. under the supervision of competent physicians. Instead they subject patients to invasive surgeries which are risky no matter what the surgery is for. Being a lung patient, I am appalled at how many people I get e-mails from stating that they were told to get on the transplant list, that there was no other option. The FDA is killing people off by their unfounded regulations against autologous stem cell therapy. Dr. Kervorkian may be gone, but the FDA lives on.