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MFDS requests supplements for porcine islet transplant trial

By Lee, Tak-Sun | translator Alice Kang

21.08.30 12:00:58

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Central Pharmaceutical Affairs Council indicated that condition for clinical trial subjects should be clear and more safety verification data is necessary



Experts from the Ministry of Food and Drug Safety expressed the opinion that supplementary data is necessary for the clinical trial protocol studying a xenotransplantation product that transplants islet cells isolated from pigs to diabetic patients.

With such an opinion issued, it seems that some time would be required before the clinical trial of a xenotransplantation product is conducted. The trial had gained much attention as being the ¡®world¡¯s first¡¯ trial on a xenotransplantation product.

On the 30th, the Ministry of Food and Drug Safety disclosed the results of the Central Pharmaceutical Affairs Council (CPAC)¡¯s ¡®Advisory meeting on the feasibility of the submitted investigato

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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