First Injections Completed in Clinical Trial of RCS-01 for Skin Aging and UV-Damaged Skin
Phase 1 clinical trial investigating the use of a patient-specific cell-based dermal rejuvenation product (RCS-01) is scheduled to deliver data in late-2016
VANCOUVER, BC — December 17, 2015 — RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, today announced that the first injections of study products have been completed in the phase 1 clinical study (NCT02391935) evaluating RCS-01, an autologous cell-based skin rejuvenation product. RepliCel is developing RCS-01 as a longer-lasting, more natural alternative to existing dermal fillers on the market which often have only short-term results.
RepliCel’s RCS-01 cell therapy uses a participant’s own replicated fibroblast cells, isolated from their hair follicles, to rebuild the collagen, elastin and other glycoproteins that provide structural support and stability to the skin’s extracellular matrix — intended to return skin back to its youthful appearance.
The single-centre study, being conducted in Germany, will evaluate the safety and tolerability of injecting RCS-01 into adult patients with aged and wrinkled skin.
“I am very pleased with the speed and efficiency with which the Düsseldorf team has been able to recruit participants for our RCS-01 trial,” commented Darrell Panich, Vice President of Clinical Affairs. “Their efforts have allowed us to complete the first injections this week and have over half of the study compliment provide biopsies before the end of 2015. This will allow for study products to be manufactured during the Christmas break and for more injections to take place in the New Year. With their continued diligence, we anticipate a conclusion of the recruitment phase of the trial in early 2016.”
Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer, added: “The treatment of our first participants in this trial is a significant step in the clinical development of RCS-01 as we explore the product’s ability to restore the dermal matrix of the skin. We believe RCS-01 represents a potential game changer in the treatment of wrinkles and aged skin, and may provide a viable minimally-invasive alternative to dermal fillers which have varying results and are not sustainable for long periods of time.”
Trial Design
The study is projected to include 30 volunteer participants selected based on their health status, current/past medications and ability to adhere to protocol-related requirements. After providing informed consent, participants will be evaluated against the study inclusion/exclusion criteria and will provide blood samples for screening assessments. If selected for participation, four treatment evaluation sites will be identified on the buttocks — two on each side and a biopsy will be taken from the scalp from which RCS-01 will be prepared. Participants will be randomized into one of two treatment groups; one will receive injections of RCS-01, placebo and a ‘sham’ injection (a needle penetration without injection of liquid) while the other (placebo) group will only receive placebo and ‘sham’ injections. The primary purpose of this study is to assess the safety profile of RCS-01 injections. The study will also measure the impact RCS-01 injections have on skin markers related to aging through evaluation of gene expression profiles. The data collected from this trial will provide crucial information on the safety of injections RCS-01 and will provide a glimpse into how the product may improve the skin’s appearance in areas of aesthetic importance. This data will also support the design of future clinical trials that will further evaluate the efficacy of RCS-01 in the treatment of UV-damaged/aged skin. For more details on the clinical trial click here.
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