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Is stem cell therapy legal in South Korea?

Published Sep 18, 2026Updated Oct 8, 2026Last verified Sep 18, 2026Requests recorded in this site’s own server logs, with the crawler identity checked by reverse DNS or IP range.Meta31Google20OpenAI6Anthropic5Ahrefs2Parallel2Apple1Microsoft1Perplexity1Yandex1First collected Sep 18, 2026Recent requestsGoogleNov 3, 2026AhrefsOct 30, 2026MicrosoftOct 27, 2026Meta · unverifiedOct 12, 2026Meta · unverifiedOct 12, 2026GoogleOct 10, 2026AhrefsOct 9, 2026Meta · unverifiedOct 9, 2026Meta · unverifiedOct 6, 2026Meta · unverifiedOct 6, 2026Meta · unverifiedOct 5, 2026Meta · unverifiedOct 4, 2026
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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.

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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]

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

  1. governmentImportant Patient and Consumer Information About Regenerative Medicine Therapies — U.S. Food and Drug Administration · accessed Nov 10, 2026 · Evidence page
  2. governmentApproved Cellular and Gene Therapy Products — U.S. Food and Drug Administration · accessed Nov 12, 2026 · Evidence page
  3. 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
  4. organizationStem Cell Resources for Patients — International Society for Stem Cell Research (ISSCR) · accessed Sep 22, 2026 · Evidence page
  5. governmentGraft-versus-host disease: MedlinePlus Medical Encyclopedia — U.S. National Library of Medicine (MedlinePlus) · accessed Nov 10, 2026 · Evidence page
  6. 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
  7. governmentAlofisel: EPAR — European Medicines Agency · accessed Nov 10, 2026 · Evidence page
  8. 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
  9. 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
  10. journalUnproven stem cell therapy for macular degeneration (Ansari ZA, Kuriyan AE, Albini TA) — Oncotarget · accessed Nov 10, 2026 · Evidence page