Dr. Joel Singer is a plastic surgeon affiliated with the Cell Surgical Network, who has publicly announced he has treated NFL player(s) with IV adipose tissue for concussions or other neurologic disorders. According to the FDA guidelines, adipose tissue digested to make SVF or made into smaller adipose tissue pieces broken down by mechanical disruption is a biologic drug. Biologic drugs need to be registered and go thru a well defined and expensive and time consuming FDA process BEFORE being approved for human use. Dr. Singer doesn’t have an Investigational Drug License or a BLA on file with the FDA so apparently, according to the FDA…he is using and promoting an unapproved biologic drug.
We only use minimally manipulated bone marrow derived stem cells because that is allowed by the FDA for homologous uses…We can’t sultry or store or bank the stem cells. According to there best legal opinions we have today, using bone marrow for orthopedic applications….a practice done for the past 100 years in various ways……is currently not regulated by the FDA.