Starting February 21, 2025, patients in South Korea suffering from severe, rare, and incurable diseases such as arthritis, autoimmune disorders, Parkinson’s disease, and cancer will have access to stem cell and immune cell therapies previously limited to clinical trials. This advancement comes with the implementation of the revised Advanced Regenerative Bio Law, enacted in 2020 to facilitate access to advanced regenerative medicine.
Key Changes Under the New Law
The revision allows hospitals and corporations to administer cell and gene therapies in the development stages, providing treatments for conditions lacking effective solutions. These include therapies involving stem cells, immune cells like T cells and NK cells, and gene-editing technologies. However, patients must first receive approval for safety and treatment plans from the Regenerative Medicine Review Committee, which reviews applications monthly.
Jeong Soon-gil – Director of the Regenerative Medicine Policy Division at the Ministry of Health and Welfare explained;
“The revised law targets diseases without treatments or serious, rare, and incurable conditions, ensuring a wide application scope.”
The new market is not covered by health insurance, and costs will vary among institutions, which currently total 112 designated regenerative medical centers.
High Demand for Regenerative Medicine
Experts predict significant demand for stem cell therapies in treating arthritis, autoimmune diseases, and respiratory conditions worsened by the COVID-19 pandemic. For arthritis, stem cells can repair cartilage, alleviating pain and improving mobility. Conditions like lupus, polycystic ovary syndrome, and congenital scoliosis may also benefit from these therapies.
Choi Seung-ho, CEO of Panacell Biotech, highlighted stem cells’ regenerative potential, noting their capacity for repairing tissues and restoring hormonal balance. Exosomes, bioactive particles derived from cells, also show promise in cell regeneration and reducing inflammation.
Promising Developments in Therapy
Several companies and research teams are advancing clinical trials:
- S.Biomedics is developing TED-A9, an embryonic stem cell treatment for Parkinson’s disease, showing early success with a patient regaining mobility.
- CHA Biotech plans to test NK cell cancer therapy CHANK-101 for glioblastoma patients.
- ENCell is trialing EN001, a mesenchymal stem cell therapy for Charcot-Marie-Tooth disease, a rare neurodegenerative disorder.
This law is expected to boost therapy development by generating extensive patient data, attracting domestic and international interest, and strengthening the financial foundations of therapy developers. These changes position South Korea as a leading player in the global regenerative medicine market, with potential parallels to Japan’s advancements in the field.
