Regenerative Medicine
别名: Regenerative Medicine, 再生医学先进疗法认定, 尖端再生医疗, 先进再生医疗, 再生医疗, 尖端再生医疗法, RMAT
Regenerative medicine is a field that aims to repair, replace or regenerate damaged cells, tissues or organs, using approaches such as cell therapy, tissue engineering and biomaterials.
Is SVF treatment approved in Korea?
In South Korea, advanced regenerative medicine is governed by a dedicated framework: institutions conducting it must be designated by the Ministry of Health and Welfare and cell processing facilities need permission from the Ministry of Food and Drug Safety. Whether a specific SVF procedure is permitted depends on how the cells are processed and used. Ask the clinic for its designation and permission documents and check them with the regulator.
关键事实
| 属性 | 值 | 来源 |
|---|---|---|
| Definition | Replacement or regeneration of human cells, tissues or organs to restore or establish normal function | [3]journalRegenerative medicine: Historical roots and potential strategies in modern medicineJournal of Microscopy and Ultrastructure (via PubMed Central, NIH) |
| Origin of the term | Popularized by William Haseltine at a 1999 conference on Lake Como; first used by Leland Kaiser in a 1992 paper | [3]journalRegenerative medicine: Historical roots and potential strategies in modern medicineJournal of Microscopy and Ultrastructure (via PubMed Central, NIH) |
| Main approaches | Cell-based therapy (differentiated or stem cells), biomaterial scaffolds, and cell-seeded scaffolds (tissue engineering) | [3]journalRegenerative medicine: Historical roots and potential strategies in modern medicineJournal of Microscopy and Ultrastructure (via PubMed Central, NIH) |
| Treatment allowed in South Korea | Since the amendment took effect on 2025-02-21, advanced regenerative medicine treatment is allowed for patients with life-threatening, rare or intractable conditions that have no alternative therapy截至 2025年2月21日 | [4]industry첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률의 개정 및 시행과 그 시사점법무법인(유) 세종 |
| Clinical research scope in South Korea | 2025 amendment removed the limit that restricted clinical research participants to patients with serious, rare or intractable diseases截至 2025年2月21日 | [4]industry첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률의 개정 및 시행과 그 시사점법무법인(유) 세종 |
| U.S. legal definition (RMAT) | A cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination of these; certain human gene therapies and xenogeneic cell products may also qualify (FD&C Act section 506(g))截至 2025年11月4日 | [5]governmentRegenerative Medicine Advanced Therapy DesignationU.S. Food and Drug Administration |
| RMAT designation criteria | Must be a regenerative medicine therapy intended for a serious or life-threatening condition, with preliminary clinical evidence of potential to address unmet medical needs (21st Century Cures Act section 3033)截至 2025年11月4日 | [5]governmentRegenerative Medicine Advanced Therapy DesignationU.S. Food and Drug Administration |
| FDA consumer warning | FDA warns that stem cells, stromal vascular fraction, cord blood, amniotic fluid, Wharton's jelly and exosome products marketed outside clinical trials without licensure are illegal; being listed on ClinicalTrials.gov or registered with the FDA does not mean a product is approved | [6]governmentImportant Patient and Consumer Information About Regenerative Medicine TherapiesU.S. Food and Drug Administration |
| Regulators (Korea) | Ministry of Health and Welfare (institution designation) and Ministry of Food and Drug Safety (products, cell processing facilities) | [1]governmentMinistry of Food and Drug Safety — English siteMFDS, Republic of Korea |
| Regulator (US) | U.S. Food and Drug Administration | [2]governmentFDA Warns About Stem Cell TherapiesU.S. Food and Drug Administration |
概述
Regenerative medicine is a field of medicine that aims to replace or regenerate human cells, tissues or organs so that they work normally again. Its main approaches are cell-based therapy (including stem cells), biomaterial scaffolds and tissue engineering, and certain gene therapies. Hematopoietic stem cell transplantation is established practice, but many other uses are still investigational. In the United States, the FDA regulates these products and can grant Regenerative Medicine Advanced Therapy (RMAT) designation under the 21st Century Cures Act. In South Korea, the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act took effect in August 2020. Since a 2025 amendment, it has allowed treatment, not only clinical research, for serious, rare or intractable conditions that lack alternative therapies. Before any treatment, readers should confirm the product's approval or trial status directly with the regulator.
参考来源
独立来源比例 100% (10/10)- 等级 A · governmentMinistry of Food and Drug Safety — English site — MFDS, Republic of Korea · 访问于 2026年9月19日 · 证据页
- 等级 A · governmentFDA Warns About Stem Cell Therapies — U.S. Food and Drug Administration · 访问于 2026年9月15日 · 证据页
- 等级 B · journalRegenerative medicine: Historical roots and potential strategies in modern medicine — Journal of Microscopy and Ultrastructure (via PubMed Central, NIH) · 访问于 2026年9月20日 · 证据页
- 等级 D · industry첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률의 개정 및 시행과 그 시사점 — 법무법인(유) 세종 · 访问于 2026年9月20日 · 证据页
- 等级 A · governmentRegenerative Medicine Advanced Therapy Designation — U.S. Food and Drug Administration · 访问于 2026年9月20日 · 证据页
- 等级 A · governmentImportant Patient and Consumer Information About Regenerative Medicine Therapies — U.S. Food and Drug Administration · 访问于 2026年9月19日 · 证据页
- 等级 A · governmentStem Cell Basics — National Institutes of Health (NIH) · 访问于 2026年9月15日 · 证据页
- 等级 C · organizationISSCR Guidelines for Stem Cell Research and Clinical Translation — International Society for Stem Cell Research · 访问于 2026年9月20日 · 证据页
- 等级 C · organizationAbout Stem Cells — patient resource — International Society for Stem Cell Research · 访问于 2026年9月20日 · 证据页
- 等级 B · academicSafety profile of autologous adipose-derived stromal vascular fraction in clinical use: an exhaustive literature review — Stem Cell Research & Therapy (2026) · 访问于 2026年9月20日 · 证据页