FDA slaps Broomfield stem-cell clinic with injunction, halting pain treatment

[LaurenG]

The Food and Drug Administration has filed an injunction to stop a Broomfield clinic from using a person's own stem cells to alleviate pain.

The FDA this month said the Regenerative Sciences clinic is violating federal standards by injecting patients with their cultured stem cells. The clinic's doctors remove cells from the patient and grow them in an outside lab before injecting the cells into painful joints.

The clinic's cell product is not approved by the FDA and no "adequate and well-controlled studies" have proved the procedure's safety or effectiveness, according to an FDA announcement.

"FDA recognizes the importance of the development of novel and promising new therapies," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, in the statement. "However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public's health at risk."


http://www.denverpost.com/ci_15834497

[hlthe2b]

1. Hmm. we allow for autotransfusions...

Stored bone marrow transplants. This seems a little less than clear cut that they have clearly violated the limits of standards and practices.... I hope they work out an agreement to comply with FDA and continue this work.

[LaurenG]

2. Yes - it would be nice

if no one had to skirt around the law.