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RepliCel's Cell Therapy for Pattern Baldness Proceeds to Clinical Trial Launch in Japan
RepliCel's Cell Therapy for Pattern Baldness Proceeds to Clinical Trial Launch in Japan.
About this update from Replicel Life Sciences Inc.
[{"type":"text","content":"\n \n \n RepliCel's Cell Therapy for Pattern Baldness Proceeds to Clinical Trial Launch in Japan\n \n \nRepliCel's Cell Therapy for Pattern Baldness Proceeds to Clinical Trial Launch in Japan\n \n VANCOUVER, BRITISH COLUMBIA--(Marketwired - Jul 21, 2016) - RepliCel Life Sciences Inc. (OTCQB:REPCF)(TSX VENTURE:RP)(FRANKFURT:P6P1), (\"RepliCel\" or the \"Company\"), a clinical-stage regenerative medicine company focused on the development of autologous cell therapies, is pleased that its RCH-01 product, for the treatment of androgenetic alopecia, is now cleared by the Japanese regulatory authorities for use in a clinical research study launching now in Japan. \n The study, designed to involve 60 men and women with thinning hair caused by androgenetic alopecia, will be conducted at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, by Drs. Tsuboi and Niiyama. Clinical endpoints will include measures of safety and efficacy based on hair fibre thickness and density. \n The study is being financed by Shiseido Company and each product being injected will be manufactured by Shiseido at their SPEC (Cell-Processing and Expansion Center) facility in Kobe, Japan. RepliCel helped Shiseido design, validate, and prepare the SPEC facility for certification by Japan's PMDA (Pharmaceuticals and Medical Device Agency). Shiseido's SPEC team was also trained by RepliCel and Innovacell in the GMP (Good Manufacturing Practice) compliant production protocols for RCH-01.\n \n The product being tested in the clinical study, RCH-01, is an autologous cell therapy developed by RepliCel. Shiseido has an exclusive marketing license to the product for certain Asian countries under a License and Co-development Agreement signed in 2013. \n As part of the Agreement between the companies, RepliCel's team trained the clinical investigatory team on critical elements of both the patient biopsy procedure and injection of the cellular product into the patient's scalp. Furthermore, the injector being used in this study mimics RepliCel's patented, first-generation injection technology. \n In the Agreement, Shiseido committed to sharing the clinical data from this study with RepliCel thus further strengthening the collective data package being created on RCH-01. While such data may be sufficient for Shiseido to bring RCH-01 to market in Japan, it ...