Nega Koreyada ildiz hujayrali davolash

• Hearticellgram-AMI (Pharmicell)

  2011-yilda ruxsat berilgan. MFDS buni ildiz hujayrali dori vositasiga dunyodagi birinchi mahsulot ruxsati sifatida qayd etgan. Hozirgi ruxsat etilgan samara — koʻkrak ogʻrigʻi paydo boʻlganidan keyin 72 soat ichida koronar angioplastika bilan reperfuziya qilingan, chap qorincha otilma fraksiyasi 40% va undan past boʻlgan oʻtkir miokard infarkti bemorlarida chap qorincha otilma fraksiyasini yaxshilash.¹²

• Cartistem (Medipost)

  2012-yil 18-yanvarda osteoartrit bilan ogʻrigan bemorlarda (ICRS grade IV) tizza togʻay nuqsonini davolash uchun ruxsat berilgan. Kindik qonidan olingan allogen mezenximal ildiz hujayralar.¹³

• Neuronata-R (Corestem)

  2014-yil iyulda kam uchraydigan kasalliklar uchun dori vositasi sifatida ruxsat berilgan; shart — tasdiqlovchi klinik sinov natijalarini topshirish. Hozirgi ruxsat etilgan koʻrsatma — riluzol bilan birga qoʻllanadigan, sekin rivojlanayotgan ALS bemorlarida kasallik rivojlanish tezligini sekinlashtirish. Bu shart bajarilgan-bajarilmaganini tasdiqlay olmadik.⁵

• Qupistem (Anterogen) — ruxsat qaytarib olingan

  2012-yil 18-yanvarda Kron kasalligidagi tuynuklarni davolash uchun ruxsat berilgan (autolog yogʻ toʻqimasidan olingan mezenximal ildiz hujayralar). Ruxsat 2026-yil 22-sentyabrda qaytarib olingan.¹⁴

Ruxsat etilgan ildiz hujayrali dori vositalarining samarasi ham faqat belgilangan koʻrsatmalar boʻyicha koʻrib chiqilgan. Boshqa kasalliklar boʻyicha samara ruxsat doirasiga kirmaydi.

1. 2025-yil 21-fevraldan Koreyada Sogʻliqni saqlash va ijtimoiy taʼminot vazirligi tayinlagan regenerativ tibbiyot muassasalari ogʻir, kam uchraydigan va davolash qiyin kasalliklari bor bemorlarga ilgʻor regenerativ tibbiyot davosini faqat qoʻmita koʻrib chiqqan davolash rejasi doirasida taqdim eta oladi.⁶⁷
2. 2026-yil iyun holatiga koʻra tayinlangan regenerativ tibbiyot muassasalari 223 ta. Faqat tayinlanishning oʻzi davolashni tasdiqlamaydi; har bir davolash rejasi alohida koʻrib chiqilishi kerak. Vazirlikning 2026-yil 21-iyuldagi eʼloniga koʻra tasdiqlangan davolash rejasi 1 ta.⁸
3. Oʻrta va yuqori xavfli davolash uchun avval shu maqsaddagi klinik tadqiqot yakunlanishi kerak. Tasdiqlangan davolash rejasi muvofiqlik xabarnomasi sanasidan boshlab eng koʻpi bilan 5 yil amal qiladi.⁶

Koreyadagi «davolash rejasini tasdiqlash» va Yaponiyadagi «taqdim etish rejasini topshirish» koʻrib chiqish tuzilmasi jihatidan farq qiladi, shuning uchun ularni bir mezonda solishtirib boʻlmaydi. Ikki raqamning yonma-yon qoʻyilishi birining ikkinchisidan ustunligini bildirmaydi.

Manbalar

Oxirgi tekshirilgan sana: 2026-10-24. Eng tez oʻzgarishi mumkin boʻlgan faktlar — Qupistem ruxsatining qaytarib olinishi va tasdiqlangan davolash rejalari soni.

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 ↗

Bu sahifa faqat maʼlumot berish uchun moʻljallangan, tibbiy maslahat emas va biror mahsulotni sotish yoki tavsiya qilish emas. Barcha faktlar yuqoridagi manbalarga asoslanadi va keyinchalik oʻzgarishi mumkin. Davolash haqidagi qarorni shifokoringiz bilan maslahatlashing.