Gangstem Biotech Decides to Voluntarily Withdraw Clinical Trial for 'Purestem-OA Kit'
[Asia Economy Reporter Myunghwan Lee] Kangstem Biotech announced on the 20th that it has decided to voluntarily withdraw the ½a phase clinical trial plan (IND) for the osteoarthritis treatment drug Purestem-OA Kit Injection.
The company explained, "Even when the investigational drug used in the clinical trial is manufactured using a cell bank, we decided to voluntarily withdraw in order to complete additional tests through culture methods beyond the existing test results to prove that quality and safety are identical."
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Yohan Bae, Head of Clinical Development at Kangstem Biotech, stated, "The IND application for Purestem-OA Kit Injection was for the first stem cell-based combination product clinical trial after the implementation of the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act. Considering this uniqueness, the Ministry of Food and Drug Safety conducted a thorough review of safety from multiple angles, which caused some delay in the IND approval process. Meanwhile, additional test data that were not previously required were also requested."
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