Non-clinical trial contract with Barunseang Hospital's Cartilage Regeneration Research Institute, HLB Biocode and HLB Biostep
Apr 29, 2025
Barunseang Hospital (Director Seo Dong-won) recently announced that it has signed a contract with HLB Biocode and HLB Biostep, which are non-clinical tests of GLP toxicity tests and in-body distribution tests for human chondrocytes treated and cultured with PRP-exosome.
This agreement marks the start of non-clinical trials to develop chondrocyte treatments for cartilage damage diseases such as degenerative arthritis, and is expected to be an important milestone for securing safety and proving the mechanism of action.
HLB Biocode, designated as a Good Laboratory Practice (GLP) certification body, is Korea's leading GLP non-clinical testing institution and will oversee toxicity testing and overall non-clinical testing of this project.
Based on the experience of testing biopharmaceuticals and cell and gene therapy drugs accumulated so far, HLB Biocode plans to derive scientific and reliable toxicity test data. In particular, the distribution test will be joined by HLB Biostep, the nation's highest level of effectiveness evaluation agency, and will be used as key data for future clinical design and licensing strategies by actively utilizing systematic analysis platforms and effectiveness evaluation capabilities based on in-body distribution analysis technology.
The Barunseang Hospital Cartilage Regeneration Research Institute (Director Lee Yong-soo) is currently carrying out the pan-ministerial regeneration medical development project, a national project organized by the Korea Research Foundation/Ministry of Health and Welfare, and has been conducting research with the goal of developing knee joint cartilage regeneration technology using platelet rich plasma (PRP)-exosome. Based on the results of the past two years of research, this year, the Ministry of Food and Drug Safety aims to apply for clinical trials (IND filing) by completing safety evaluations such as toxicity and distribution in the body using animal models. In addition, Barunseang Hospital is an advanced regeneration medical practice institution and plans to submit a plan related to advanced regeneration clinical research to the Ministry of Health and Welfare within this year.
Lee Yong-soo, head of the research institute, said "With no osteoarthritis drug treatments so far, research is underway to develop various cell treatments using stem cells or processed chondrocytes at various specialized companies and pharmaceutical companies. In this regard, the development material of the cartilage regeneration research institute at our institute is drawing attention because it is a treatment with an approach similar to the MACI (autologous cartilage cells cultured on pig collagen membranes) of Vericel, the highest-selling articular cartilage treatment in the U.S. market, with FDA approval. If this non-clinical trial secures sufficient effectiveness and safety and achieves objective results in clinical trials or clinical studies, it is expected that it will be able to preempt the osteoarthritis treatment market as a practical cell therapy" he said.
This agreement marks the start of non-clinical trials to develop chondrocyte treatments for cartilage damage diseases such as degenerative arthritis, and is expected to be an important milestone for securing safety and proving the mechanism of action.
HLB Biocode, designated as a Good Laboratory Practice (GLP) certification body, is Korea's leading GLP non-clinical testing institution and will oversee toxicity testing and overall non-clinical testing of this project.
Based on the experience of testing biopharmaceuticals and cell and gene therapy drugs accumulated so far, HLB Biocode plans to derive scientific and reliable toxicity test data. In particular, the distribution test will be joined by HLB Biostep, the nation's highest level of effectiveness evaluation agency, and will be used as key data for future clinical design and licensing strategies by actively utilizing systematic analysis platforms and effectiveness evaluation capabilities based on in-body distribution analysis technology.
The Barunseang Hospital Cartilage Regeneration Research Institute (Director Lee Yong-soo) is currently carrying out the pan-ministerial regeneration medical development project, a national project organized by the Korea Research Foundation/Ministry of Health and Welfare, and has been conducting research with the goal of developing knee joint cartilage regeneration technology using platelet rich plasma (PRP)-exosome. Based on the results of the past two years of research, this year, the Ministry of Food and Drug Safety aims to apply for clinical trials (IND filing) by completing safety evaluations such as toxicity and distribution in the body using animal models. In addition, Barunseang Hospital is an advanced regeneration medical practice institution and plans to submit a plan related to advanced regeneration clinical research to the Ministry of Health and Welfare within this year.
Lee Yong-soo, head of the research institute, said "With no osteoarthritis drug treatments so far, research is underway to develop various cell treatments using stem cells or processed chondrocytes at various specialized companies and pharmaceutical companies. In this regard, the development material of the cartilage regeneration research institute at our institute is drawing attention because it is a treatment with an approach similar to the MACI (autologous cartilage cells cultured on pig collagen membranes) of Vericel, the highest-selling articular cartilage treatment in the U.S. market, with FDA approval. If this non-clinical trial secures sufficient effectiveness and safety and achieves objective results in clinical trials or clinical studies, it is expected that it will be able to preempt the osteoarthritis treatment market as a practical cell therapy" he said.
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This article was translated by Naver AI translator.
