Court Enjoins Stem Cell Treatment
Stephen Barrett, M.D.
The U.S. District Court for the District of Columbia has ordered Regenerative Sciences of Broomfield, Colorado and three of its employees (Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever) to stop performing their Regenexx stem cell procedure in the United States . The complaint in the case was filed in August 2010 by the Justice Department on behalf of the FDA.
Drs. Centeno and Schultz practice together and jointly own the Centeno-Schultz Clinic in Broomfield. They are also the majority shareholders of Regenerative Sciences, which owns the Regenexx™ Procedure and licenses the clinic to use it. Centeno is also the medical director, chief executive officer of Regenerative Sciences. Ms. Sheever serves as Regenerative's laboratory director. The Regenexx Web site lists 12 additional clinics that it says have been licensed to provide the treatment.
The Regenexx procedure is intended for patients suffering from moderate to severe joint, muscle, tendon or bone pain due to injury or other conditions. Regenerative Sciences has described it this way:
The Regenexx Web stated that as of March 1, 2012 the clinic had performed approximately 1,300 of these procedures on more than 920 distinct patients (some patients received multiple reinjections). 
The Regenexx™ Procedure begins with a licensed physician taking a small bone marrow sample from the back of a patient's hip through a needle. Blood samples are also taken from a vein in the patient's arm. These samples are then sent to the Regenerative laboratory which is also in Broomfield, Colorado . . . where the mesenchymal stem cells (MSCs) are isolated from the bone marrow and then grown to greater numbers. . . . Once the cells pass quality assurance testing, they are placed back into the patient's injured area (i.e. knee, hip, rotator cuff), typically 4-6 weeks after they were removed. The stem cells then begin to repair the patient's degenerated or injured area. The repair process usually takes between 3-6 months but many patients demonstrate marked improvement within 1-3 months .
In 2008, the FDA sent Dr. Centeno a warning letter stating that it regarded the cells used in the Regenexx procedure as drugs subject to FDA regulation and that Regenerative Sciences was not complying with the relevant federal laws and regulations . FDA investigators inspected the clinic in 2009 and 2010 and concluded that the laboratory did not comply with current good manufacturing practices . The lawsuit—filed after the FDA concluded that the company had failed to make sufficient corrections—charged that:
- The cultured cell product is not approved by the FDA.
- No adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.
- The product was also misbranded due to the lack of adequate directions for use and the failure to bear the "Rx only" symbol.
- The company violated good manufacturing practices that cause its cultured cell product to be adulterated .
Regenerative Sciences argued that the FDA lacked jurisdiction because (a) they were only practicing medicine within Colorado and (b) the Regenexx procedure is not a drug subject to federal regulation. In an interview in Forbes Magazine before the decision was issued, Centeno stated that he welcomed the lawsuit because it would give them a chance to formally question the FDA on its policy .
In July 2012, the judge granted a permanent injunction under which the procedure could not be used again unless the company complied with FDA regulations . The company has appealed this ruling.
In 2001, Centano founded the Centano Clinic Foundation, which changed its name to the Spinal Injury Foundation in 2002 and the International Cellular Medicine Society (ICMS) in 2009. Federal tax returns list him and Dr. Schultz as directors. The ICMS Web site describes it as "is an international non-profit dedicated to patient safety through strict evaluation of protocols and rigorous oversight of clinics and facilities engaged in the translation of point-of-care cell-based treatments." ICMS operates an Institutional Review Board (IRB) and has set up a registry intended to follow-up patients for up to 20 years. In June 2012, the FDA inspected the IRB and found eight types of deficiencies .
- Collyer RM. Memorandum opinion. USA v. Regenerative Sciences, filed July 23, 2012.
- Statement appears in memorandum opinion on pages 2-3.
- Welcome to Regenexx™ - Advanced Stem Cell Procedures Regenex.com hone page, accessed Nov 25, 2012.
- Malarky MA. Warning letter to Christopher J. Centeno, M.D.
- Complaint. USA v. Regenerative Sciences, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. U.S. District Court for the District f Columbia. Civil action No. 10-01327, filed Aug 6, 2010.
- Koleva G. Stem cells and the lawsuit that may shape our medical future. Forbes, Feb 10, 2012.
- Inspection report of ICMS IRB, June 19, 2012.
This article was revised on November 27, 2012.