RepliCel Life Sciences, a clinical stage regenerative medicine company focussed on the development of autologous cell therapies, announced the submission of a Clinical Trial Application (CTA) to the German Competent Authority, the Paul-Ehrlich-Institut (PEI), requesting clearance to initiate a phase 1 clinical trial investigating the use of RCS-01 to treat patients suffering from aged and UV-damaged skin. RCS-01 is a cell-based product highly expressive of type 1 collagen comprised of autologous, cultured fibroblast cells isolated from the non-bulbar dermal sheath (NBDS) of the hair follicle.
The study, entitled, “Randomised, double-blind, placebo-controlled, single-centre, phase 1 safety study of intra-dermal injections of RCS-01 in male and female subjects (50 to 65 years old)”, addresses the inherent deficit of active fibroblasts required for the production of type 1 collagen, elastin and other critical extracellular dermal matrix components found in youthful skin. If cleared to proceed, the proposed trial will be conducted at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany.
“Skin aging is caused by a reduction in metabolically active fibroblasts, disorganization of collagen fibrils and decreased production of collagen, elastin and other glycoproteins that provide structural support and stability to the extra cellular matrix. We believe that RCS-01 has the potential to reverse the signs of aging by providing RepliCel’s UV-naïve collagen-producing fibroblast cells directly into affected areas of the skin. This trial is an important step toward the development of a cell-based treatment for fine wrinkle lines which are typically seen in the face, hands and other UV-affected areas,” commented Dr. Rolf Hoffmann, RepliCel’s chief medical officer.
“RCS-01 is the second product, utilising our hair follicle-derived fibroblasts, that we anticipate entering clinical testing in 2015 the first being RCT-01 for chronic tendinosis. While the primary endpoint of this trial is to demonstrate the safety of RCS-01 injections into the skin, the trial is also designed to collect quantitative and qualitative data demonstrating the product’s effects, at a molecular level, on skin aging and UV-damage,” stated David Hall, RepliCel’s CEO. “This fibroblast-based program should be viewed as a broad platform which we will apply to multiple indications characterised by tissue damage and incomplete healing. We anticipate data from these NBDS trials (RCS-01 and RCT-01) will contribute to the early establishment of the commercial value of our fibroblast platform.”
“Initiation of this trial is another milestone in our 18-month strategy to create maximum value around the company’s fibroblast program,” stated Lee Buckler, RepliCel’s vice-president of Business and Corporate Development. “In addition to our clinical trial programs, our team is working on manufacturing optimisation involving state-of-the-art bioreactor technology and serum-free media, development of a proprietary injector device to reduce the human variability of our product injections, and pre-clinical research validating the immune-privilege of both our cell platforms in order to support the potential for allogeneic use of RepliCel’s products.”