Official certifications and licenses of the Stem Cell Research Center
Having the equipment does not mean cells can be handled just anywhere.
Advanced Regenerative Medicine Institution designation · Cell Processing Facility License
The center has received designation as an Advanced Regenerative Medicine Institution and a Cell Processing Facility License from the Ministry of Health and Welfare and the Ministry of Food and Drug Safety. They were granted under Article 10(1) (designation of institutions) and Article 15(1) (cell processing facility license) of the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products.
- Institution designation
- Minister of Health and Welfare · Designation No. 재생-1-0049 · May 21, 2025
- Cell Processing Facility License
- Head of the Seoul Regional Office of Food and Drug Safety · License No. 139 · February 10, 2026 · Valid until February 9, 2029 (renewed every 3 years)
- Cells handled
- Autologous (adipose-derived stem cells) — as stated on the license
What it means for patients: The facilities, equipment, staff and standard operating procedures (SOPs) for handling cells are reviewed and managed against government standards. It is also the legal precondition for handling everything from harvesting to isolation and storage in-house, without outsourcing.
Recognition as a dedicated R&D department
The center has been recognized by the Ministry of Science and ICT as a dedicated R&D department under Article 14-2(1) of the Basic Research Promotion and Technology Development Support Act and Article 27(1) of its Enforcement Decree. A dedicated R&D department is an organization in which a company, to promote its own technology development, assigns at least one dedicated researcher and conducts research in an independent space. It is run by research staff with master's or doctoral degrees in biology.
- Recognition
- Korea Industrial Technology Association (KOITA, commissioned by the Ministry of Science and ICT) · Certificate issued April 21, 2023 · First recognized September 15, 2017
What it means for patients: The name "research center" has an official basis. Dedicated researchers conduct research in an independent space.
What the designation means, and what it does not
A designation or license shows that the standards set by law have been met. It does not mean the government guarantees the effectiveness or safety of individual procedures, and the government regards promoting a designation in that way as false or exaggerated advertising. The research center keeps to this distinction.
| What the designation and license mean | What they do not mean |
|---|---|
| The facilities, equipment, staff and SOPs were reviewed and met the standards set by law | Every procedure performed at this institution is advanced regenerative medicine |
| Advanced regenerative medicine research and treatment plans can be submitted to the review committee | The government has verified or guaranteed the effectiveness or safety of a particular procedure |
| Required staff complete designated training and bear management obligations | Plans that have not been approved can be carried out freely |
| The quality and safety of the facilities for harvesting, processing and storing human cells are managed | Cosmetic procedures fall under "advanced regenerative medicine treatment" in the amended Act |
The two systems have different authorities and purposes
| Item | Advanced Regenerative Medicine Institution designation | Cell Processing Facility License |
|---|---|---|
| Legal basis | Advanced Regenerative Bio Act, Article 10 | Advanced Regenerative Bio Act, Article 15 |
| Authority | Ministry of Health and Welfare | Ministry of Food and Drug Safety |
| Covered activities | Conducting advanced regenerative medicine clinical research and treatment | Harvesting, testing, processing, storing and supplying human cells, etc. |
| Review focus | Systems for conducting research and treatment safely | Facilities, equipment and staff to manage cell quality and safety |
| Ongoing obligations | Completing training, complying with provision standards (mandatory plan submission within 1 year of designation and a 3-year renewal system are being introduced) | License renewed every 3 years |
| SC301 Clinic | 재생-1-0049 (2025-05-21) | No. 139 (2026-02-10) |
This explanation of the systems is based on public information as of October 2026 and may change as laws are amended. For a detailed explainer, see the research note "What is an Advanced Regenerative Medicine Institution?" (Korean).
You can check for yourself
| Item | Verifying body | How to check |
|---|---|---|
| Advanced Regenerative Medicine Institution | Ministry of Health and Welfare · Advanced Regenerative Medicine portal | Search the list of regenerative medicine institutions at k-arm.go.kr for "SC301의원" or designation No. 재생-1-0049 (Korean site) |
| Cell Processing Facility License | Ministry of Food and Drug Safety | Check License No. 139 in MFDS's list of licensed cell processing facilities for advanced biological products · A copy of the license can be viewed at the research center |
| Dedicated R&D department | Korea Industrial Technology Association | Search for "SC301의원" in the research institute and R&D department registration system (rnd.or.kr, Korean site) |
The numbers and dates above are taken from the documents posted on the clinic website and from the research notes.
This site does not use expressions that go beyond the scope of the designation and license. Please send questions about scope via Contact the research center.