RepliCel Applies for Manufacturing Approval for its Collagen and Tissue Regeneration Cell Therapies
Clinical development of RepliCel’s skin rejuvenation and tendon regeneration injectables continues to meet milestones on path to commercialization in Japan
VANCOUVER, BC -- 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 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.
About RCS-01 Skin Rejuvenation Cell Therapy
RCS-01 is an autologous cell therapy regenerative product comprised of cells highly expressive of type 1 collagen and other tissue-building protein. The product is developed, manufactured, and injected to regenerate the extracellular matrix under aging and/or sun-damaged skin characterized by fine wrinkles and loss collagen structure.
A randomized, double-blind, placebo-controlled, single-centre, phase I clinical study evaluated RCS-01 produced statistically and clinically significant positive data revealing a nearly two-fold increase in gene expression of collagen-related biomarkers in the skin, after a single injection of RCS-01. The study observed the impact of the injection on ten different biomarkers that, in peer-reviewed medical literature, are highly correlated with skin aging and chronically sun-damaged skin. Notably, gene expression markers, such as tissue inhibitors of metalloproteinases (TIMP), showed significant changes expected to correlate with increased collagen fibers. Increased collagen production, and reduced collagen degradation, is associated with fewer wrinkles and the repair of sun-damaged skin.
The observation that injection of NBDS-derived cells is associated with an increased transcriptional expression of these genes indicates the possibility that cell therapy treatment with RCS-01 might ameliorate the clinical and aesthetic signs of skin aging, such as wrinkles. This assumption is in line with observations that increased expression of collagen type 1 and type 3 is a prerequisite for wrinkle reduction caused by retinol.
“The molecular markers assessed in this study were all related to skin aging. The data suggests the cell therapy can affect the marker expression in a way that indicates that skin aging can be counteracted by being treated with this product. In other words, we believe the data indicates the effects of skin aging can potentially be reversed,” stated is Professor Jean Krutmann, Professor of Dermatology and Environmental Medicine and Director of the IUF Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University Düsseldorf.
About RepliCel’s First-in-Japan Strategy
RepliCel was one of the first foreign regenerative medicine companies to have a Japanese partnership in 2013. In 2015 RepliCel was one of the first foreign regenerative medicine companies to initiate a consultation process, under the new regulations for regenerative medicine products, with Japan’s PMDA (Pharmaceuticals and Medical Device Agency). In 2016, RepliCel’s licensee, Shiseido Company, was one of the first companies to fund and manufacture a product for use in a clinical study under the newly legislated Act for the Safety of Regenerative Medicine (ASRM).
RepliCel aims to be one of the first foreign regenerative medicine companies based outside of Asia to directly engage in a clinical study of a cell therapy product under the ASRM regulatory pathway to commercialization. RepliCel will also be one of the first such companies to apply for certification of a manufacturing facility outside of Asia for the production of a cell therapy product to be imported for use in a clinical study governed by the ASRM regulations.
About RepliCel's Programs in Japan
RepliCel is currently preparing for the clinical testing and commercialization of three additional technologies in Japan. These include two cell therapies - one for skin rejuvenation and one for tendon regeneration - and a next-generation dermal injector for aesthetic treatments involving a wide variety of injectable substances including cells, PRP, muscle paralysis toxins, fillers, enzymes, drugs, other biologics, etc.
The RepliCel cell therapy technology which is the subject of active, ongoing partnership discussions in Japan has already been the subject of two successfully completed consultations with Japan's Pharmaceutical and Medical Devices Agency (PMDA). Planning for clinical research studies under Japan's Act for the Safety of Regenerative Medicines (ASRM) is already underway. Manufacturing of the clinical product will be performed by a Japanese-owned contract manufacturer preparing now for PMDA-certification under Japan's Ministry of Health, Labour, and Welfare (MHLW) applicable guidelines. Conduct of the clinical research studies will be managed by a high-quality Japanese clinical research organization.
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