RepliCel Launches Preparations for Second Skin Rejuvenation and Tendon Regeneration Clinical Studies. Clinical research organization, Accerise Inc., has been retained to work with RepliCel and its other service providers to prepare study documentation, plans, and approvals for clinical evaluation by multiple clinical sites in Japan.
VANCOUVER, BC, CANADA – 19 May 2021 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that it has retained leading clinical research organization, Accerise Inc, with offices in Tokyo and Osaka, to lead the planning and preparations for clinical research studies of RepliCel’s skin rejuvenation (RCS-01) and tendon regeneration (RCT-01) cell therapy products in Japan.
Accerise will support RepliCel’s clinical advisors, Professor Morita and Professor Kumai, in the design of the clinical study protocols, procuring the collaboration of all clinical sites, obtaining all necessary approvals from institutional research boards (IRBs), oversight committees, and the Ministry of Health, Labour and Welfare (MHLW) 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 cell therapies have been the subject of successful phase 1 studies in Germany and Canada. The next-phase clinical research studies in Japan will be conducted under that country’s Act for Safety of Regenerative Medicine (ASRM) and, upon successfully meeting its endpoints, could lead to a commercial launch of the products in Japan.