A lot of confusion over biologic "birth products" and exosomes — Austin OrthoBiologics explains

A lot of confusion over biologic "birth products" and exosomes —

these are products used in regenerative medicine, distinct from your own cell-based “stem cells” and PRP (platelet rich plasma).

Perhaps due to recent changes to NIH, HHS, and especially FDA leadership with the new administration, there seems to be renewed interest in birth products, such as cord blood, placental tissue and Wharton's jelly, and their potential as orthobiologic treatments. At Austin OrthoBiologics, we have seen an increase in phone calls and questions about these products.

For numerous reasons, FDA regulations essentially prohibit the orthopedic/joint injection of "birth products" unless used in an FDA-approved IND clinical trial. These trials are lengthy and very expensive, and therefore are few & far between....

Same rules apply for exosomes, another form of biologic “packaging“ to deliver these products. Noted regenerative medicine expert Chris Centeno MD states “exosomes require full FDA approval with clinical trials. However, no exosome product being sold today has that type of biologic drug approval…The myth spread by many sales reps selling exosomes has been that if the company has an FDA IND and permission to perform a clinical trial on a specific disease, that company can sell its exosome products to the public. That contention is, of course, fiction…”

The FDA position has been clear on this issue since at least 2022.

The companies that sell these FDA–prohibited products are well aware of the restrictions - many have received FDA warning letters and more.

However, the doctors asked to consider injecting these may not be.

It is our responsibility as healthcare providers to keep up with the regulations of a high growth and rapidly evolving specialty, as we at Austin OrthoBiologics strive to do. This is not a “static” area of medicine. Changes to treatment protocols will occur and regulations will follow.

Currently and perhaps most importantly –

We find no reason to skirt regulations in our treatment protocols - your own cell-based therapy "stem cells” and PRP for orthopedic, joint pain, and early arthritis indications work well at just about any age. Our experience of 10 years and over 2500 procedures with well-documented successful patient outcome studies (re:databiologics.com) bears this out.

Feel free to reach out to us in Austin with any questions.

Kelly Cunningham, MD

Board-certified orthopedic surgeon

Austin OrthoBiologics

austinorthobio.com

(512)-410-0767

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