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
About RCT-01 Tendon Regeneration Cell Therapy
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.
'Chronic tendinopathy is a state of tendon degeneration that is very difficult to reverse, as evidenced by the many therapies used to try and treat it,' stated Dr.
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 of 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 peerreviewed 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
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
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