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FDA Acts on Unapproved Cell Therapy

The FDA is seeking to stop a Colorado company from offering an autologous stem cell therapy for arthritic knees and other orthopedic problems saying that the therapy is unapproved, misbranded and adulterated.

Regenerative Sciences of  Broomfield, Colo., markets a procedure called Regenexx in which mesenchymal stem cells are isolated from a patient’s bone marrow, expanded in vitro, and then re-injected into painful or damaged joints along with certain drugs.

The FDA said the procedure has not been approved;

  • “No adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication,” the FDA stated;
  • As a result, the FDA has asked for a federal court order that would stop the company from producing the cultured cell product;
  • In addition to the lack of approval, the agency cited violations of current good manufacturing practice (cGMP) guidelines “that cause its cultured cell product to be adulterated;
  • The product is also misbranded due to the lack of adequate directions for use and the failure to bear the ‘Rx only’ symbol.”

The FDA indicated that it had warned the company about the cGMP violations in June. ”

  • Regenerative Sciences failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law,” the agency charged;
  • However, it DID indicated that Regenerative Sciences had agreed to halt production of cultured cells while the case is pending;
  • The company’s website asserts that the procedure should be considered approved because it “is compliant with CFR 21 Part 1271 and falls under the same-day surgery exemption discussed in 1271.15.” The website touts the procedure as an “alternative to traditional surgery” for joint problems in the knees, hands, hips, ankles, elbows, shoulders, and back, as well as for non-union bone fractures. (HWM and John Grever, MedPage Today)