Is stem cell therapy legal in South Korea?
Published Sep 18, 2026Updated Sep 19, 2026Last verified Sep 18, 2026Requests recorded in this site’s own server logs, with the crawler identity checked by reverse DNS or IP range.Google6Yandex1First collected Sep 18, 2026Recent requestsGoogleSep 20, 2026GoogleSep 19, 2026GoogleSep 19, 2026GoogleSep 19, 2026GoogleSep 19, 2026GoogleSep 18, 2026YandexSep 18, 2026
Quick answer
Yes, within limits. The Ministry of Food and Drug Safety has approved several stem cell products, including Cellgram-AMI, Cartistem, Cupistem and Neuronata-R. Since a February 2025 amendment to Korea's advanced regenerative medicine law, designated institutions may also offer investigational cell therapies to patients with life-threatening, intractable or rare diseases. Each treatment plan needs approval from a central committee, and patients pay the full cost.
64 words10 sources
Answer
Approvals under the treatment system last five years. Legal analysts have raised concerns about reviewer conflicts of interest and long-term safety monitoring.[9]
Sources
- governmentImportant Patient and Consumer Information About Regenerative Medicine Therapies — U.S. Food and Drug Administration · accessed Sep 19, 2026 · Evidence page
- governmentApproved Cellular and Gene Therapy Products — U.S. Food and Drug Administration · accessed Sep 19, 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 Sep 20, 2026 · Evidence page
- organizationStem Cell Resources for Patients — International Society for Stem Cell Research (ISSCR) · accessed Sep 20, 2026 · Evidence page
- governmentGraft-versus-host disease: MedlinePlus Medical Encyclopedia — U.S. National Library of Medicine (MedlinePlus) · accessed Sep 20, 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 Sep 20, 2026 · Evidence page
- governmentAlofisel: EPAR — European Medicines Agency · accessed Sep 20, 2026 · Evidence page
- organizationFDA Approves Remestemcel-L-Rknd for Steroid-Refractory Acute Graft-Versus-Host Disease in Pediatric Patients — Oncology Nursing Society · accessed Sep 20, 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 Sep 20, 2026 · Evidence page
- journalUnproven stem cell therapy for macular degeneration (Ansari ZA, Kuriyan AE, Albini TA) — Oncotarget · accessed Sep 20, 2026 · Evidence page