We Can’t Use Adipose In A Joint or For Tendon/Ligaments! (source: FDA)

The 2020 AAOM virtual meeting is going on right now!

Today (12/6/2020) in a Q&A led expertly by Sean Mulvaney, MD,
Dr. Peter Marks, Director of CBER of the FDA gave important….albeit unofficial…advice on current FDA thoughts on adipose tissue.

See Video:   CLICK HERE

I am paraphrasing the questions but the content is accurate.
Question #1 “Can a clinician use adipose (SVF) or microfat (ala Lipogems) in a knee joint or for tendinopathy?”

Answer #1 No

Question #2 “Can a clinician use fat without manipulation, other than rinsing, in a remote location for cushioning?”

Answer #2 Maybe

I have friends using adipose and gathering data and doing research. It is important research that needs to be done if we going to get IND/BLA and ultimate FDA approval for this orthobiologic for typical orthopedic pathologies. RIght now, I worry about the medico-legal risk of using an unapproved biologic drug….even if the FDA isn’t stopping me…the plaintiff’s attorney could come after me and I am not sure if my malpractice would cover my use of an unapproved biologic drug per the FDA Director of CBER.

 

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