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.
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.