Seoul Yes Hospital announced on the 21st that it has been designated as an advanced regenerative medicine facility approved by the Ministry of Health and Welfare.

The Ministry accepted applications for 2024 Advanced Regenerative Medicine Implementation Institutions from April 18 to December 27 of last year, and following the review process, a total of 19 medical institutions were designated as new Advanced Regenerative Medicine Implementation Institutions at the end of last year. Seoul Yes Hospital was also selected as one of these 19 institutions.

Advanced regenerative medicine refers to innovative medical technologies that replace or regenerate damaged human cells or organs through stem cell, gene, or tissue engineering therapies to restore normal function. It is a field attracting global attention as it offers new opportunities to treat serious, rare, and intractable diseases that are difficult to treat with existing pharmaceuticals.

Advanced regenerative medicine institutions are medical facilities authorized to conduct clinical research related to advanced regenerative medicine using human cells, genes, or tissues. Pursuant to Article 10 of the “Advanced Regenerative Bio Act,” they must be designated as such by the Minister of Health and Welfare.

They must meet all necessary conditions, including facilities, equipment, personnel, and standard operating procedures (SOPs), required for conducting advanced regenerative medicine research. Additionally, essential personnel—such as the principal investigator, research staff, human cell manager, and information manager—must complete training courses designated by the Minister of Health and Welfare.

Seoul Yes Hospital submitted its application last year and, following procedures such as document verification and on-site inspections, was officially designated as an advanced regenerative medicine institution on December 23.

This designation of Seoul Yes Hospital as an advanced regenerative medicine institution marks the first such designation among hospital-level medical institutions located in Yongin Special Self-Governing City.

In particular, considering that 83 of the 112 designated medical institutions are tertiary general hospitals and general hospitals, the hospital explains that Seoul Yes Hospital’s designation as an advanced regenerative medicine institution—despite being a hospital-level facility—signifies that it possesses research infrastructure and capabilities on par with those of tertiary general hospitals or university hospitals.

Dr. Lee Gil-yong, Director of Seoul Yes Hospital (Neurosurgeon), stated, ““Having been officially selected as an advanced regenerative medicine institution, we will devote ourselves to clinical research that can help treat not only patients suffering from spinal or joint diseases but also those struggling with intractable pain of unknown origin,” he said. “We have already completed preparations for low- and medium-risk advanced regenerative clinical trials, and our goal is to present medical solutions for the treatment of intractable diseases through the results of these clinical studies.”

Meanwhile, Seoul Yes Hospital received approval for its in-house cell processing facility from the Ministry of Food and Drug Safety (MFDS) in conjunction with its designation as an advanced regenerative medicine institution.

A cell processing facility is a facility that processes and manipulates human cells or tissues. In accordance with the Advanced Regenerative Medicine Act, it must produce cells used in clinical research in-house and comply with management standards and operational procedures equivalent to those of a Good Manufacturing Practice (GMP) facility for pharmaceuticals. Stem cells cultured through this facility may only be supplied to designated advanced regenerative medicine institutions.