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Are 줄기세포 시술 (stem cell procedures) approved?

Published Sep 18, 2026Updated Sep 19, 2026Last verified Sep 18, 2026
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Quick answer

Only a few are. In the US, the FDA says the only approved stem cell products are cord-blood-derived blood-forming stem cells for blood disorders. The EU has approved Holoclar for one type of eye injury. Korea had approved four stem cell therapeutics as of 2019. Since 21 February 2025, Korean law also lets designated institutions offer regenerative treatment under approved plans for serious, rare or intractable diseases.

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Answer

The approved uses are narrow [6][7][9][10]. Blood stem cell transplantation is the most established stem cell treatment [5].

Sources

  1. governmentStem Cells — MedlinePlus, U.S. National Library of Medicine · accessed Sep 19, 2026 · Evidence page
  2. governmentNCI Dictionary of Cancer Terms: stem cell — National Cancer Institute (NCI) · accessed Sep 20, 2026 · Evidence page
  3. academicEmbryonic Stem Cell Lines Derived from Human Blastocysts (Thomson et al., Science 282:1145–1147) — Science (AAAS); course copy hosted by University of Illinois · accessed Sep 19, 2026 · Evidence page
  4. newsNobel Prize in Physiology or Medicine 2012 awarded for discovery that mature cells can be reprogrammed to become pluripotent — ScienceDaily (Nobel Assembly at Karolinska Institutet release) · accessed Sep 19, 2026 · Evidence page
  5. governmentStem Cell Transplants in Cancer Treatment — National Cancer Institute · accessed Sep 19, 2026 · Evidence page
  6. governmentHoloclar – EPAR — European Medicines Agency · accessed Sep 20, 2026 · Evidence page
  7. governmentImportant Patient and Consumer Information About Regenerative Medicine Therapies — U.S. Food and Drug Administration · accessed Sep 19, 2026 · Evidence page
  8. organizationStem Cell Resources for Patients — International Society for Stem Cell Research (ISSCR) · accessed Sep 20, 2026 · Evidence page
  9. news규제 완화 3년 허가 0건...안풀리는 줄기세포치료제 — 데일리팜 (Dailypharm) · accessed Sep 19, 2026 · Evidence page
  10. industry첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률의 개정 및 시행과 그 시사점 — 법무법인(유) 세종 · accessed Sep 20, 2026 · Evidence page
  11. journalA Comparative Analysis of the Advances in Stem Cell Therapy in Plastic Surgery: A Systematic Review of Current Applications and Future Directions — Cureus (via PubMed Central) · accessed Sep 19, 2026 · Evidence page