Since the investigation by the national institution has been completed on the clinical trial plan of the treatment method that the venture company in Kyoto City is advancing to produce blood component called platelets from iPS cells and administer it to patients, the company is reviewing at medical institutions. After that, I would like to start clinical trials by the end of the year.
This was announced on the 26th by the bio-venture company "Megakaryon" in Kyoto City.
The company is conducting a clinical trial in which iPS cells produce platelets necessary for hemostasis from iPS cells and administer them to patients with "thrombocytopenia" in order to obtain national approval. We are proceeding with the plan.
According to the company, the clinical trial plan was submitted to PMDA (Pharmaceuticals and Medical Devices Agency), a national institution that examines drugs, etc., and the investigation was completed.
The plan is to produce platelets from third-party iPS cells donated by Kyoto University and actually administer them to about 10 adult men and women to confirm their safety and efficacy over a year.
According to the company, platelets used for treatment currently rely on blood donation, but if they can be produced from iPS cells, mass production will be possible, so at the Kyoto University Hospital where we plan to actually administer them in the future. After undergoing a new review, we hope to start administration by the end of the year if approved.