Why Korea for stem cell therapy

• Hearticellgram-AMI (Pharmicell)

  Approved in 2011. MFDS describes it as the world's first marketing approval of a stem cell therapy product. The current approved indication is improvement of left ventricular ejection fraction in acute myocardial infarction patients with an ejection fraction of 40% or less who were reperfused by coronary angioplasty within 72 hours of chest pain onset.¹²

• Cartistem (Medipost)

  Approved on 18 January 2012 for the treatment of knee cartilage defects in osteoarthritis patients (ICRS grade IV). Allogeneic umbilical cord blood-derived mesenchymal stem cells.¹³

• Neuronata-R (Corestem)

  Approved in July 2014 as an orphan drug, conditional on submitting confirmatory trial results. The current approved indication is slowing disease progression in slowly progressing ALS, in combination with riluzole. We could not confirm whether the condition has been met.⁵

• Qupistem (Anterogen) — approval withdrawn

  Approved on 18 January 2012 for Crohn's fistula (autologous adipose-derived mesenchymal stem cells). The approval was withdrawn on 22 September 2026.¹⁴

Approved stem cell products were evaluated only for their specific approved indications; effects in other conditions are not part of the approval.

1. Since 21 February 2025, institutions designated by Korea's Ministry of Health and Welfare may provide advanced regenerative treatment to patients with serious, rare or intractable diseases, but only under treatment plans that have passed review by the national review committee.⁶⁷
2. As of June 2026 there were 223 designated regenerative medicine institutions. Designation alone does not authorize treatment; each treatment plan requires separate review. As of the Ministry's release of 21 July 2026, one treatment plan has been approved.⁸
3. Medium- and high-risk treatments require a completed clinical study with the same purpose first. An approved treatment plan is valid for up to five years from the date of the notice of approval.⁶

Korea's “treatment plan approval” and Japan's “provision plan submission” are different review structures and cannot be compared on one axis. Placing the two numbers side by side does not mean one country is ahead of the other.

Sources

Last reviewed: 2026-10-24. The facts most likely to change are the Qupistem withdrawal and the number of approved treatment plans.

1. [1]MFDS (Korea Food and Drug Administration), 2012 Drug Approval Report, p.49, Feb 2013. States that Hearticellgram-AMI received the world's first marketing approval of a stem cell therapy product in 2011; Cartistem and Qupistem approved 18 Jan 2012 (table 23). korea.kr ↗
2. [2]MFDS Drug Safety Portal (nedrug), Hearticellgram-AMI, item 202106185. Checked 24 Oct 2026. Current approved indication (changed 27 Feb 2026): improvement of left ventricular ejection fraction in reperfused acute myocardial infarction patients with LVEF of 40% or less. nedrug.mfds.go.kr ↗
3. [3]MFDS Drug Safety Portal (nedrug), Cartistem, item 202106062. Checked 24 Oct 2026. Approved for knee cartilage defects in osteoarthritis patients (ICRS grade IV); allogeneic umbilical cord blood-derived mesenchymal stem cells. nedrug.mfds.go.kr ↗
4. [4]MFDS Drug Safety Portal (nedrug), Qupistem, item 202106133. Checked 24 Oct 2026. Approved for Crohn's fistula; marketing authorization withdrawn 22 Sep 2026. A search for "stem cell" returns these four products only. nedrug.mfds.go.kr ↗
5. [5]MFDS Drug Safety Portal (nedrug), Neuronata-R, item 202106193. Checked 24 Oct 2026; MFDS press release, 31 Jul 2014. Orphan drug approved Jul 2014 on condition of submitting confirmatory trial results (deadline moved to 30 Apr 2025 by the 16 Feb 2024 variation). Indication changed 26 May 2026 to slowing progression in slowly progressing ALS patients, in combination with riluzole. Whether the condition has been met is not confirmed. nedrug.mfds.go.kr ↗
6. [6]Act on Advanced Regenerative Medicine and Advanced Biological Products, articles 2, 10, 12-2 and the addenda (as in force on 24 Oct 2026). Designation of regenerative medicine institutions by the Minister of Health and Welfare; treatment only under plans that passed committee review; target diseases limited to serious, rare or intractable; plan valid up to five years; Act promulgated 27 Aug 2019 and in force 28 Aug 2020; amendment in force 21 Feb 2025. law.go.kr ↗
7. [7]Ministry of Health and Welfare, press release, 19 Feb 2025. Treatment under the amended Act starts on 21 February 2025. mohw.go.kr ↗
8. [8]Ministry of Health and Welfare, press release, 21 Jul 2026. 223 designated regenerative medicine institutions (June 2026); one treatment plan approved (April 2026). Designation is not treatment approval. mohw.go.kr ↗
9. [9]MHLW (Japan), Act on the Safety of Regenerative Medicine, law no. 85 of 2013, and overview. Promulgated 27 Nov 2013, in force 25 Nov 2014; provision plans classified by risk into class 1 to 3. mhlw.go.jp ↗
10. [10]MHLW (Japan), status of enforcement of the Act on the Safety of Regenerative Medicine, as of 30 Jun 2026. Provision plans: treatment 6,743 (class 1: 8, class 2: 2,463, class 3: 4,272); research 85. mhlw.go.jp ↗
11. [11]PMDA (Japan), approved regenerative medical products, review reports. Temcell approved Sep 2015; Stemirac Dec 2018 (conditional, time-limited); Alofisel Sep 2021; HeartSheet: full approval rejected (as of 24 Jul 2024); Collategene: marketing authorization expired. HeartSheet is a skeletal myoblast sheet and Collategene is a gene therapy; neither is a stem cell product. pmda.go.jp ↗
12. [12]JST Science Portal, 18 Mar 2026. RiHEART (severe heart failure from ischemic cardiomyopathy) and AMCHEPRY (Parkinson's disease), both allogeneic iPS cell-derived products, approved 6 Mar 2026, conditional and time-limited (7 years). scienceportal.jst.go.jp ↗

This page is for information only. It is not medical advice and not an offer or recommendation of any product. Every fact rests on the sources above and may change later. Discuss any treatment decision with your doctor.