RepliCel Life Sciences Inc. announced it has submitted its application to Japan's Ministry of Health, Labour, and Welfare (MHLW) for approval to manufacture the Company's RCT-01 cell therapy for chronic tendinopathy and RCS-01 cell therapy for aging and sun-damaged skin for its upcoming clinical studies. With successful phase 1 studies complete, RepliCel is currently preparing for clinical research of its skin rejuvenation (RCS-01) and tendon regeneration (RCT-01) cell therapies in Japan under the Act for Safety of Regenerative Medicine (ASRM) which, upon successfully meeting its endpoints, could lead to the commercial launch of the products in Japan. The MHLW manufacturing approval of these products for clinical research will extend to commercial production of these same products. The Company's team in Tokyo includes industry advisors CJ Partners, clinical research organization Accerise, Professor Akimichi Morita of Nagoya City University Hospital, and Professor Tsukasa Kumai of Waseda University all contributing to RepliCel's clinical development and commercialization plans for its tissue regeneration cell therapy product portfolio in Japan. A phase 1 clinical study of RCT-01 in patients with chronic, refractory Achilles tendinopathy successfully met its primary endpoint of establishing a complete safety profile with no serious adverse events related to the study treatment or injection procedure. Each of the treated participants, all of whom suffered chronic tendon pain and loss of function over an extended period of time with no recovery from standard treatments, showed numerous clinically important improvements by various measures including tendon composition, blood supply, physical function and pain sensation.