Medipost has initiated its global expansion by completing the first patient registration and treatment in the U.S. Phase 3 clinical trial of its umbilical cord-derived allogeneic mesenchymal stem cell therapy, Cartistem.
On July 8, Medipost announced that it has finished the first patient registration and treatment in the U.S. Phase 3 trial. This trial, conducted at major institutions in the U.S. and Canada, targets patients with knee osteoarthritis and is expected to be a pivotal moment for Cartistem's global market entry.
The company is conducting the Phase 3 trial with 300 patients suffering from moderate to severe knee osteoarthritis across more than 70 sites in the U.S. and Canada. The recruitment and dosing phase will last approximately two years, followed by a two-year follow-up to evaluate structural improvements and clinical symptom relief.
After the trial concludes, Medipost plans to prepare a Clinical Study Report (CSR) and sequentially submit a Biologics License Application (BLA). The company aims to demonstrate the potential of Cartistem as a disease-modifying osteoarthritis drug (DMOAD) through this trial.
Notably, this trial is being conducted under a Single Pivotal Study designation granted by the U.S. Food and Drug Administration (FDA). Typically, the FDA requires two or more independent Phase 3 trials for approval, but Medipost received single trial approval based on clinical data from Korea and Japan, as well as domestic long-term real-world evidence (RWE).
Alongside the U.S. clinical trial, Medipost plans to accelerate its global market strategy through local business development (BD).
Lee Seung-jin, head of Medipost's Global Business Division, stated, "The first patient dosing in the U.S. Phase 3 trial is a significant milestone for our global market entry. We aim to prove the therapeutic value of Cartistem in the U.S. and change the treatment paradigm for knee osteoarthritis."
Cartistem, approved in South Korea in 2012, has been used in over 36,000 procedures for severe knee osteoarthritis. Recently, it demonstrated efficacy and safety in a Phase 3 trial in Japan, prompting the company to expedite its global approval process.
Previously, Medipost announced plans to apply domestically developed media for the commercialization project of Cartistem in Japan.
Media is a nutrient solution essential for cell growth, determining cell proliferation and characteristics. Currently, South Korea relies heavily on imports for most media. Consequently, the need for domestic production has been consistently raised in terms of supply chain stability and industrial competitiveness.
The domestic production project will utilize 'CellCor MSC CD AOF,' a specialized chemical composition media for mesenchymal stem cells developed and produced by Excel Therapeutics.
On July 8, Medipost announced that it has finished the first patient registration and treatment in the U.S. Phase 3 trial. This trial, conducted at major institutions in the U.S. and Canada, targets patients with knee osteoarthritis and is expected to be a pivotal moment for Cartistem's global market entry.
The company is conducting the Phase 3 trial with 300 patients suffering from moderate to severe knee osteoarthritis across more than 70 sites in the U.S. and Canada. The recruitment and dosing phase will last approximately two years, followed by a two-year follow-up to evaluate structural improvements and clinical symptom relief.
After the trial concludes, Medipost plans to prepare a Clinical Study Report (CSR) and sequentially submit a Biologics License Application (BLA). The company aims to demonstrate the potential of Cartistem as a disease-modifying osteoarthritis drug (DMOAD) through this trial.
Notably, this trial is being conducted under a Single Pivotal Study designation granted by the U.S. Food and Drug Administration (FDA). Typically, the FDA requires two or more independent Phase 3 trials for approval, but Medipost received single trial approval based on clinical data from Korea and Japan, as well as domestic long-term real-world evidence (RWE).
Alongside the U.S. clinical trial, Medipost plans to accelerate its global market strategy through local business development (BD).
Lee Seung-jin, head of Medipost's Global Business Division, stated, "The first patient dosing in the U.S. Phase 3 trial is a significant milestone for our global market entry. We aim to prove the therapeutic value of Cartistem in the U.S. and change the treatment paradigm for knee osteoarthritis."
Cartistem, approved in South Korea in 2012, has been used in over 36,000 procedures for severe knee osteoarthritis. Recently, it demonstrated efficacy and safety in a Phase 3 trial in Japan, prompting the company to expedite its global approval process.
Previously, Medipost announced plans to apply domestically developed media for the commercialization project of Cartistem in Japan.
Media is a nutrient solution essential for cell growth, determining cell proliferation and characteristics. Currently, South Korea relies heavily on imports for most media. Consequently, the need for domestic production has been consistently raised in terms of supply chain stability and industrial competitiveness.
The domestic production project will utilize 'CellCor MSC CD AOF,' a specialized chemical composition media for mesenchymal stem cells developed and produced by Excel Therapeutics.
* This article has been translated by AI.
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