Regenerative Sciences, Inc
July 25, 2008
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Christopher J. Centeno, M.D.
Medical Director
Regenerative Sciences, Inc.
11080 Circle Point Road
Building 2, Suite 140
Westminster, Colorado 80020
Dear Dr. Centeno:
The Food and Drug Administration (FDA) has reviewed your website at Internet address: http://www.regenexx.com and has determined that you are promoting your use of mesenchymal stem cells under conditions that cause these cells to be drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products, as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. 262].
Based on information posted on your website, mesenchymal stem cells utilized in your Regenexx™ procedure are drawn from a patient's bone marrow, sent to a lab, isolated, and then grown using growth factors drawn from the patient's blood before being inserted back into the patient. These cells are considered drugs because the therapeutic claims shown on your website demonstrate that they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man. In describing the use of mesenchymal stem cells in the Regenexx™ procedure your web site states, among other things, that: “Regenerative Sciences, Inc., has launched its patent-pending Regenexx™ procedure, which uses a patient’s own stem cells to regenerate bone and cartilage – a welcome relief for the more than 20 million Americans who suffer from painful and debilitating orthopedic conditions.” Your website also states “The procedure relieves pain and restores mobility and is a safer, less disruptive alternative to surgery”; and “With Regenexx™ almost anyone with joint pain or non-healing fractures can benefit from this groundbreaking procedure.”
Further, your website contains personal testimonials that constitute therapeutic claims. The testimonials on your website include, but are not limited to, the following:
K.D. states “I dealt with knee pain and the problems for a long time, . . . I would absolutely recommend that anybody with osteoarthritis check out Dr. Centeno and Regenerative Sciences.”
P.G. states “I would recommend the Regenexx™ procedure in a heartbeat to anyone who’s dealing with joint injuries or osteoarthritis.”
J.A. states “I want the whole world – especially seniors – to know that injuries such as femoral, hip and pelvic fractures don’t have to diminish your quality of life. You can be healthy and moving forward again with this procedure.”
Please be advised that in order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application in effect as specified by FDA regulations (21 U.S.C. 355(i); 21 CFR Part 312). The mesenchymal stem cells utilized in your Regenexx™ procedure are not the subject of an approved biologics license application (BLA) nor is there an investigational new drug application (IND) in effect. Therefore, your implantation of the mesenchymal stem cells for which a valid license or IND is not in effect appears to violate the Act and the PHS Act and may result in FDA seeking relief as provided by law.
The mesenchymal stem cells used in your procedure are human cells, tissues, or cellular and tissue-based products (HCT/Ps) as defined in 21 CFR § 1271.3(d). Under 21 CFR Part 1271, HCT/Ps are not subject to licensure or IND requirements if certain criteria are met (21 CFR § 1271.10). However, these criteria are not met here because the mesenchymal stem cells used in your procedure are intended for non-homologous uses (21 CFR § 1271.10(a)(2); 21 CFR § 1271.3(c)).
This letter is not intended to be an all-inclusive review of your website and the procedures/products that your firm may promote and/or market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and the PHS Act and their implementing regulations.
We request that you notify this office, in writing, of the steps you have taken or will take to address the violations noted above and to prevent their recurrence. Your response should be sent to me at the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200 N, Rockville Maryland 20852-1448.
If you have any questions regarding this matter, you may contact Ms. Anna M. Flynn at (301) 827-6201. Please be advised that only written communications are considered official.
Sincerely,
/Mary A. Malarkey/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Enclosure: Internet website pages from http://www/regenexx.com
cc: Mr. Matthew Fulton
President
Regenerative Sciences, Inc.
11080 Circle Point Road
Building 2, Suite 140
Westminster, Colorado 80020