Stem Cells May Prevent Need for Joint Replacements, if FDA Allows It

Stem Cells May Prevent Need for Joint Replacements, if FDA Allows It (press release)

TUCSON, Ariz., June 1, 2011 /PRNewswire-USNewswire/ — Patients’ own adult stem cells show great potential in regenerative medicine, including orthopedic applications. Stem cells isolated from bone marrow can enable bone and cartilage to heal.

Once removed, the patients’ cells are processed and allowed to multiply in tissue culture. Then they are injected back into the knee joint of the same patient. The meniscus of the knee can be repaired, despite its poor blood supply.

Preliminary studies show that many patients with osteoarthritis might be able to avoid a total knee replacement with this therapy. If only 10 percent of total knee joint replacements could be averted, about 500 deaths from surgical complications could be prevented each year.

Development may, however, be stalled by the Food and Drug Administration’s attempt to impose costly, onerous regulations that treat the processing of the cells like mass production of a drug. The FDA is quite inconsistent in its regulation of cellular therapy. In vitro fertilization, for example, has a specific exemption from the FDA’s regulatory framework, despite the extensive manipulation of the cells.

Although all medical procedures carry risk, hundreds of follow-up contacts and MRIs have shown no higher rate of complications with stem-cell therapy than with other injection-based treatments. Since the patients’ own cells are used, there are no public health risks of disease transmission.

The FDA’s picking of parts of medical practice for special treatment is “capricious, and ultimately harmful to the advancement of medical science and alleviation of human suffering,” writes Dr. Christopher Centeno, who has pioneered the method, in the summer 2011 issue of the Journal of American Physicians and Surgeons, the official journal of the Association of American Physicians and Surgeons.



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