FDA to Step Up Stem Cell Enforcement. That’s Good News for Physicians and Consumers

When it comes to regenerative medicine, the FDA has a unique challenge. They are charged with protecting consumers from questionable practices while, at the same time, helping to ensure that patients have access to beneficial procedures and meaningful advancements. As part of the Regenexx network, which pioneered the regenerative procedures we use in our practice, we applaud their efforts.

We believe in total transparency for consumers. Patients must be able to easily determine which products or procedures are permitted by the FDA, and which are not, as well as the reasons why. In the markets we serve and across the country, Regenexx physicians have spent countless hours answering questions, conducting seminars, writing articles and posts, and even taking questions on Facebook Live because we want to make sure patients have accurate information in this rapidly evolving environment.

Regenexx has published a great deal of all orthopedic-stem-cell research worldwide and holds 15 patents on various Interventional-Orthopedic technologies and protocols. Our procedures are permitted by the FDA because they use your body’s own bone marrow concentrate containing living stem cells or PRP in a same-day procedure. Specially trained physicians use precise image guidance to place your cells in a place where they have the best chance of providing benefit–often reducing the need for invasive surgery.

The FDA created a regenerative medicine policy framework in 2017 in order to help expedite innovation. This helps get beneficial therapies to patients quickly after they’ve been determined to be safe and effective. At the same time, they have granted some enforcement leeway to providers of stem cell “products.” That grace period came to an end May 31st, and enforcement will proceed. We see this as good news, as it will remove ineffective, unscrupulous, or even dangerous products from the marketplace, while permitting physicians to practice regenerative medicine.

You can read more about the FDA’s updates in this recent post on the FDA blog by Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research.

https://www.fda.gov/news-events/fda-voices/advancing-development-safe-and-effective-regenerative-medicine-products

About The Author
James Leiber, DO

James Leiber, DO

James Leiber, DO, is founder and medical director of Regenexx® at New Regeneration Orthopedics.

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