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Korea will conduct clinical research on culturing and injecting mesenchymal stem cells from fetal bone tissue into patients with the rare and incurable disease osteogenesis imperfecta.
The Ministry of Health and Welfare said Friday that the Ministry of Food and Drug Safety gave final approval early this month to a high-risk clinical research plan to culture and use mesenchymal stem cells from fetal bone tissue in patients with osteogenesis imperfecta. The plan was approved by the eighth Advanced Regenerative Medicine and Advanced Biologics Review Committee in 2024.
A clinical study of culturing and injecting mesenchymal stem cells from fetal bone tissue into patients with rare and incurable osteogenesis imperfecta will be conducted in Korea. (Credit: Getty Images)
A clinical study of culturing and injecting mesenchymal stem cells from fetal bone tissue into patients with rare and incurable osteogenesis imperfecta will be conducted in Korea. (Credit: Getty Images)
“The study is expected to alleviate the symptoms of patients with osteogenesis imperfecta, a rare disease, by using fetal-derived stem cells, which have superior bone differentiation capabilities compared to other tissue-derived stem cells and are known to secrete bone formation-promoting proteins,” the ministry said.
Three clinical research plans submitted by regenerative medical institutions—9988 Orthopedic Surgery Center, Catholic University of Korea Seoul St. Mary's Hospital, and Konkuk University Medical Center—were rejected as inappropriate at Thursday's third review committee meeting of 2025.
The review committee also discussed the types of research or treatment plans that require on-site surveys and the details of such surveys and decided to consult with relevant organizations to ensure that they take root in accordance with the law's purpose.
According to the recently revised Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, the enforcement decree of the Advanced Regenerative Medicine Act, and the enforcement rules of the Advanced Regenerative Medicine Act. the review committee can request the Minister of Health and Welfare to conduct an on-site inspection to determine if it is necessary to verify that the facilities, equipment, manpower, and the way of receiving human cells are according to the clinical research plan and treatment plan for advanced regenerative medicine submitted by the regenerative medicine organization.
“The committee secretariat has prepared the ‘Guidelines for Reviewing and Writing Advanced Regenerative Medicine Treatment Plans’ and posted them on the ‘Advanced Regenerative Medicine Portal,’” said Kim Woo-ki, secretary general of the review committee. “We will strive to ensure that the newly introduced or changed systems under the revised Advanced Regenerative Bio Act are implemented without disruptions.”
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Kim Kyoung-Won kkw97@docdocdoc.co.kr
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