Stem Cell Therapy

Machine-translated from Korean

Approved Therapies
World's first product approval according to KFDA data (2011)
According to data from the Ministry of Food and Drug Safety, Korea was the first in the world to grant product approval for a stem cell therapy in 2011. To date, four products have been approved, and as of October 2026, the approval of three products remains in effect.
Regulatory Trust
Effects reviewed only within the scope of authorization
The efficacy of approved stem cell therapies has been reviewed only for designated indications. Advanced regenerative medicine treatments at medical institutions may only use cells supplied from licensed cell processing facilities.
Regenerative Medicine Act
Treatment permitted from 2025 (subject to review)
Starting February 21, 2025, designated regenerative medicine institutions may provide treatment to patients with serious, rare, or intractable diseases only for treatment plans that have undergone review. Designation alone does not grant approval for treatment.

Source MFDS Drug Safety Korea · Ministry of Health and Welfare Press Release (2026-07-21) · Advanced Regenerative Biotechnology Act

Recommended Hospitals

Only signed-in members can view patient reviews.