it would have to have the FDA approval if it were stem cells from another person, now that they are stem cells from patients own material it is not necessary, you can find this in the procedure of CAVERSTEM and FEMCELZ also no FDA approval was required as far as I know
To do your part to stay safe, make sure that any stem cell treatment you are considering is either:
FDA-approved, or; Being studied under an Investigational New Drug Application (IND), which is a clinical investigation plan submitted and allowed to proceed by the FDA.