We take our role serving as stewards for our members and the Interventional Orthopedics medical sub-specialty seriously. Recently, our industry has faced several threats including the ban on stem cell therapies in Canada. We have also seen the publication of several troubling articles attacking stem cell therapies without fully examining the issue, such as this New York Times article.

In response, Interventional Orthopedics Foundation (IOF) President Gerard Malanga has issued a response to the New York Times article. IOF has also hosted a webinar discussing the Health Canada Policy Paper regarding the ban, the FDA’s response to the New York Times article and the steps IOF is taking to ensure that physicians safely practicing regenerative medicine in the U.S. are able to continue doing so.

CLICK HERE AND REGISTER TO VIEW A RECORDING OF DR. MALANGA’S WEBINAR

One of the largest threats to our field are unscrupulous clinicians using less than adequate technique and the companies that supply them with ineffective products that purport to contain live stem cells but do not.

As we pioneer and develop the medical sub-specialty of Interventional Orthopedic Medicine, this issue has several implications for the Interventional Orthopedics and regenerative medicine industries. A coalition of IOF member physicians, academics and regulatory experts have published a consensus statement concerning the aggressive marketing of these non-viable birth tissues as live “stem cell” products to cure chronic disease. IOF is encouraging physicians in our industry to be properly trained through our courses and building our community to be strong presence within the medical industry.

IOF continues to monitor this issue closely. This week one of our members exchanged correspondence with the FDA regarding the compliance of Chara Biologics products with FDA standards. Our member inquired after receiving claims from Chara Biologics representatives that the company’s products contain  live stem cells and are FDA compliant. This is NOT the case. Please see below for the FDA’s response regarding the issue.

For additional questions regarding the compliance of orthobiologic products, please contact:

Center for Biologics Evaluation and Research

Office of Communications, Outreach and Development

U.S. Food and Drug Administration

Tel: 800-835-4709

[email protected]

Thank you for contacting the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER).

FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications. All of the approved stem cell-based products are included in the list at the following link; however none of those products are sponsored by Chara Biologics, Inc. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.

As I mentioned in my response of May 23, 2019, The regulations in 21 CFR Part 1271 identify the criteria for regulation solely under Section 361. HCT/Ps that meet all of the criteria in 21 CFR Section 1271.10(a) are regulated solely under Section 361 of the PHS Act. If all of the criteria in 21 CFR Section 1271.10 are met then no pre-market review (application to FDA) is required. To satisfy these criteria, an HCT/P must be: No more than minimally manipulated (relates to the nature and degree of processing); intended for homologous use only (the product performs the same basic function in the donor as in the recipient); not combined with another article (with some limited exceptions); and the HCT/P does not have a systemic effect and is not dependent on the metabolic activity of living cells for its primary function, or if it does, the HCT/P is intended for autologous use or use by a first-or second-degree blood relative.

HCT/Ps that do not meet all of the criteria of 21 CFR Section 1271.10 are also regulated under Section 351 of the PHS Act and/or the Federal Food, Drug and Cosmetic Act as drugs, devices and/or biological products and would require pre-market approval.

Additionally, it is important to know that HCT/P facilities are regulated by FDA. As such, these establishments are required to register with FDA. Please note that being registered with FDA does not mean a firm is in compliance with FDA regulations. Registration with FDA means that an establishment has notified FDA of its business address and their HCT/Ps. Registration enables FDA to know what HCT/P establishments are open for business so periodic inspections can be performed.  The FDA does not approve or accredit facilities.

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