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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Kangstem Biotech Participates in Government-Led Clinical Research on Advanced Regenerative Medicine for Knee Osteoarthritis
05
2026.08
- Kangstem Biotech Joins Government-Led Advanced Regenerative Medicine R&D Program, Expected to Help Meet Domestic Demand for Overseas Treatment
Kangstem Biotech announced on August 5 that it will participate as a cell processing facility responsible for the manufacturing and supply of an autologous adipose-derived stem cell therapy for the “Advanced Regenerative Medicine Clinical Research on Knee Osteoarthritis Using Autologous Adipose-Derived Stem Cells,” which was approved by the Advanced Regenerative Medicine Review Committee. The study will be conducted at three medical institutions, including the Severance Hospital. As a multicenter clinical research study, it will evaluate the efficacy and safety of intra-articular administration of autologous adipose-derived stem cells in 165 patients with knee osteoarthritis.
The study is expected to be conducted over approximately two years and, if its efficacy and safety are demonstrated, has the potential to lead directly to actual patient treatment at the participating medical institutions, effectively serving as a fast-track pathway.
The project is being promoted in accordance with the South Korean government’s R&D strategy for advanced regenerative medicine, with the aim of accumulating clinical evidence for advanced regenerative medicine in diseases with unmet medical needs, such as degenerative arthritis, establishing a treatment infrastructure in Korea, and bringing overseas medical tourism demand for such treatments into the domestic healthcare system.
In this study, Kangstem Biotech will be responsible for the entire process of manufacturing and supplying cells required for the clinical administration of autologous adipose-derived stem cells. Building on its GMP manufacturing and quality management capabilities accumulated through the development of umbilical cord blood-derived stem cell therapies, the company plans to leverage its expertise in the autologous adipose-derived stem cell field to enhance clinical reliability and the reproducibility of research outcomes.
The Head of Kangstem Biotech’s GMP Center said, “Through years of stem cell therapy development and GMP manufacturing, the company has established an end-to-end operational and quality management system covering the entire process from cell selection to storage, thawing, preparation, and release. These integrated operational capabilities represent a key competitive advantage of Kangstem Biotech and will provide stable support for the successful execution of this multicenter clinical research.”
The company also expects this study to create meaningful synergies with OSCA, its osteoarthritis treatment currently under development. The cell manufacturing, supply and operational experience accumulated through the multicenter clinical research, together with the company’s collaborative network with major tertiary general hospitals, is expected to provide an important foundation for advancing OSCA’s clinical development and commercialization strategies.