WASHINGTON, D.C. — The District of Columbia Circuit U.S. Court of Appeals on Feb. 4 said the federal government can regulate a company that cultures stem cells for injection in the donor patient and said a lower court did not err in permanently enjoining the company from violating federal drug regulations (United States of America v. Regenerative Sciences, LLC., et al., No. 12-5254, D.C. Cir.).[Enhanced opinion available to lexis.com subscribers.]
Dr. Christopher Centeno, Dr. John Schultz, Michelle Cheever and Regenerative Sciences LLC offered a medical therapy marketed as the Cultured Regenexx Procedure to treat certain orthopedic conditions. In the procedure, a sample of a patient’s bone marrow or synovial fluid is extracted and the mesenchymal stem cells (MSCs) are isolated.
The MSCs are cultured until they divide and proliferate. The MSCs are then combined with the antibiotic doxycycline, and the mixture is injected into the patient.
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Dr. Christopher Centeno, Dr. John Schultz, Michelle Cheever and Regenerative Sciences LLC offered a medical therapy marketed as the Cultured Regenexx Procedure to treat certain orthopedic conditions. In the procedure, a sample of a patient’s bone marrow or synovial fluid is extracted and the mesenchymal stem cells (MSCs) are isolated.
The MSCs are cultured until they divide and proliferate. The MSCs are then combined with the antibiotic doxycycline, and the mixture is injected into the patient.
continue to read here