RepliCel Life Sciences has retained clinical research organization, Accerise, to lead the planning and preparations for clinical research studies of RepliCel's skin rejuvenation and tendon regeneration cell therapy products in Japan. Accerise will support RepliCel's clinical advisors in the design of the clinical study protocols, procuring the collaboration of all clinical sites, obtaining necessary approvals from institutional research boards, oversight committees, and the Ministry of Health, Labour, and Welfare including certification, training, and the establishment of the necessary systems for independent clinical study management to ensure the studies produce high-quality GCP-compliant data. This will also include certification of RepliCel's contract manufacture for the manufacture of RepliCel's cell therapy products for use in these clinical studies. Both the cell therapies have been successful phase 1 studies in Germany and Canada.
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