How do I know if a stem cell clinic is legitimate?
Ask for published preclinical studies that independent experts have reviewed, approval from an ethics review board, and authorization from a national regulator such as the FDA, EMA or MFDS. Also ask for a written protocol and a consent form. The ISSCR lists these warning signs: testimonial-based claims, one treatment for many unrelated diseases, an unclear cell source, claims of no risk, and high or hidden costs.
Answer
Get a second opinion from an independent physician, and do not rush the decision.[4] U.S. consumers can contact the FDA before starting a regenerative product, and can report harms through MedWatch.[1]
Stem cells in cosmetic surgery
In cosmetic surgery, "stem cell" procedures almost always use adipose-derived stem cells. The stromal vascular fraction (SVF), which contains them, is separated from liposuctioned fat and mixed into the fat being grafted, as in stem cell breast augmentation and stem cell fat grafting.
Sources
- governmentImportant Patient and Consumer Information About Regenerative Medicine Therapies — U.S. Food and Drug Administration · accessed Nov 10, 2026 · Evidence page
- governmentApproved Cellular and Gene Therapy Products — U.S. Food and Drug Administration · accessed Nov 12, 2026 · Evidence page
- journalOne and a half million hematopoietic stem cell transplants: continuous and differential improvement in worldwide access with the use of non-identical family donors (Niederwieser D, et al., Haematologica 107(5):1045-1053) — Haematologica · accessed Nov 10, 2026 · Evidence page
- organizationStem Cell Resources for Patients — International Society for Stem Cell Research (ISSCR) · accessed Sep 22, 2026 · Evidence page
- governmentGraft-versus-host disease: MedlinePlus Medical Encyclopedia — U.S. National Library of Medicine (MedlinePlus) · accessed Nov 10, 2026 · Evidence page
- journalMesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World (Fernández-Garza LE, et al., Pharmaceuticals 16(9):1334) — Pharmaceuticals (MDPI) · accessed Nov 10, 2026 · Evidence page
- governmentAlofisel: EPAR — European Medicines Agency · accessed Nov 10, 2026 · Evidence page
- organizationFDA Approves Remestemcel-L-Rknd for Steroid-Refractory Acute Graft-Versus-Host Disease in Pediatric Patients — Oncology Nursing Society · accessed Nov 10, 2026 · Evidence page
- journalNew legal category of 'advanced regenerative medicine treatment' in Korea's amended regenerative medicine law: comparative lessons from Japan (Yoon, Lee, Kim) — Stem Cell Reports · accessed Nov 10, 2026 · Evidence page
- journalUnproven stem cell therapy for macular degeneration (Ansari ZA, Kuriyan AE, Albini TA) — Oncotarget · accessed Nov 10, 2026 · Evidence page