And THAT is EXACTLY what BHRT is doing. Removing the cells from the body and "manipulating/modifying" them in a "lab" environment, and then re-inserting them into the body.
Case closed, IMO. That court case and the FDA prevailed. The wording is clear. The defendant was trying to argue the very "biologics" exemption that keeps getting repeated, and they lost, and lost again on appeal. Simple as that IMO.