What a Designated Advanced Regenerative Medicine Institution Is
Cellon Dermatology Clinic, Cheongdam, Seoul — In Korea, treatments that separate, culture, and reintroduce a patient's own cells are regulated separately from ordinary dermatology. Under Article 10 of the Advanced Regenerative Bio Act, a clinic may perform them only after the Ministry of Health and Welfare has inspected its facilities, equipment, and personnel and granted designation. Cellon received this designation in 2025.
Why the designation is difficult to obtain
Advanced regenerative medicine involves separating cells from the patient's body, processing or culturing them outside the body, and administering them again. Contamination, degradation, or mishandling at any point — collection, processing, storage, administration — carries real risk. The Ministry therefore examines the physical facility, the equipment, the personnel qualifications, and the standard operating procedures before granting designation.
Designation was historically concentrated in university hospitals. Its extension to clinic-level institutions is recent, and the number of designated clinics remains small.
What the designation does and does not mean
It does not guarantee a treatment outcome. No designation can do that, and any clinic suggesting otherwise is overstating it.
What it does mean is narrower and more concrete: the facility, the handling procedure, and the personnel were examined by the state before any cell-based treatment was permitted. A clinic without designation cannot legally perform these treatments in Korea at all.
How Cellon is set up
- Multi-source cell platform
- Adipose, blood, and bone marrow sources are handled in one place, so the source can be selected according to the patient's tissue characteristics and the treatment goal.
- Class 10,000 clean facility
- Processing takes place in a closed clean system to limit contact with outside air.
- Single-use collection kits
- Reusable collection instruments are not used.
- HBOT integration
- Hyperbaric oxygen therapy can be combined before and after cell administration. See Hyperbaric Oxygen Therapy.
Procedure summary
| Item | Details |
|---|---|
| Designating authority | Ministry of Health and Welfare, Republic of Korea |
| Legal basis | Advanced Regenerative Bio Act, Article 10 |
| Year designated | 2025 |
| Scope | Cell therapy, gene therapy, and tissue-engineering therapy within the approved plan |
| Facility | In-house stem cell laboratory, Class 10,000 clean environment |
| Review requirement | Each research plan is submitted and reviewed before it may be performed |
| International patient registration | Registered healthcare provider for international patients, No. M-2023-01-08-7145 (Seoul Metropolitan Government, valid through 26 June 2029) |
| Directed by | Dr. Kang Seunghoon, board-certified dermatologist |
How the procedure works
- Consultation — Dr. Kang reviews medical history, current medication, the intended indication, and regulatory eligibility.
- Determination of whether the case falls within an approved plan. If it does not, the treatment is not performed.
- Cell collection, processing, and administration are carried out under the designated protocol.
- Standardised photographic follow-up at 1, 3, and 6 months.
Indications and contraindications
- Best candidates
- Adults considering cell-based regenerative treatment who want to confirm that the institution is authorised to perform it.
- Limited benefit
- Designation applies to procedures within the approved plan. Treatments outside that scope are not covered by it.
- Contraindications
- Determined per treatment and per patient at consultation. Pregnancy, active malignancy, active infection, and certain autoimmune conditions are commonly excluding.
- Side effects
- Varies by treatment. Injection-site swelling, bruising, and transient tenderness are the most common. All adverse events should be reported to the clinic.
Frequently asked questions
Does the designation guarantee that a treatment will work?
No. The designation concerns facilities, procedures, and personnel — not outcomes. It means the state examined how cells are handled here before permitting the treatment, and that unverified methods are not used.
Can any dermatology clinic perform stem cell treatment in Korea?
No. Under the Advanced Regenerative Bio Act, only designated institutions may perform advanced regenerative medicine. Clinics without designation cannot legally do so.
Is the designation permanent?
It is not a one-time clearance. Each research plan must be submitted and reviewed before it can be carried out, and the institution remains subject to the standards it was designated under.
Does Cellon have its own laboratory?
Yes. Cellon established and operates its own stem cell laboratory with a Class 10,000 clean environment.
Can international patients receive these treatments?
Eligibility is confirmed individually. Cellon is a registered healthcare provider for international patients (No. M-2023-01-08-7145). Patients living outside Korea should confirm both clinical suitability and their own jurisdiction's rules before travelling.
How is this different from a clinic that simply advertises stem cells?
The difference is whether the institution is authorised and inspected. Marketing language is not regulated in the same way that cell handling is.
Regulatory references
- Ministry of Health and Welfare, Republic of Korea: mohw.go.kr
- Korean Ministry of Food and Drug Safety (MFDS): mfds.go.kr
- Related: Stem Cell Treatment Program