RepliCel Life Sciences has received approval to conduct a phase 1 trial in healthy volunteers investigating the potential of its skin rejuvenation product, RCS-01, to treat intrinsic aging of the skin, skin wrinkling and solar degeneration of the skin. RepliCel’s non-bulbar dermal sheath-derived fibroblast therapy (RCS-01) provides a promising treatment for these conditions by providing UV-naÃ¯ve collagen-producing cells directly to affected areas. RepliCel’s unique manufacturing technology allows for isolation of fibroblasts derived from anagen-hair follicle mesenchymal tissue, which elicit efficient replication potential in culture. Furthermore, the proprietary culture conditions in which RCS-01 is manufactured should enable these cells to maintain their inherent ability to adapt to their microenvironment and respond to the surrounding stimuli after injection, leading to robust, natural production of type 1 collagen, elastin and other extracellular proteins within the tissue. The goal is to develop a first-of-its-kind treatment for fine wrinkles on sun-damaged skin.
VANCOUVER, BC — September 1, 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 it has received approval from the Paul Ehrlich Institute (PEI), the regulatory body responsible for approving all cell-based clinical trials in Germany, to conduct its RCS-01 skin rejuvenation clinical trial. PEI approval clears the way for site initiation and patient recruitment to be conducted at the IUF Leibniz-Institut fÃ¼r umweltmedizinische Forschung GmbH in Germany. To learn more about the trial or to determine if you meet eligibility criteria, please visit https://www.clinicaltrials.gov/ or click here.
“We are pleased to have received PEI’s approval to conduct our skin rejuvenation trial. We believe RCS-01 provides a better alternative to fillers currently available on the market that include hyaluronic acid and the results of which fade over a relatively short period. RepliCel’s autologous cell therapy uses a subject’s own replicated fibroblast cells to rebuild the collagen, elastin and other glycoproteins that provide structural support and stability to the extra cellular matrix — potentially returning skin back to its youthful appearance,” commented Dr. Rolf Hoffmann, Chief Medical Officer. “According to the American Society of Plastic Surgeons, 5,497,212 injectable procedures were performed in 2014 costing $2,317,396,347. We believe RepliCel’s autologous product will be preferred by most patients who would rather inject a filler comprised of their own fibroblast cells into their skin.”
“RCS-01 initiation approval in Germany represents a second clinical trial based on RepliCel’s non-bulbar dermal sheath fibroblast (NBDS) platform to be initiated this year, the first being RCT-01 in Canada. Given the estimated time frame for enrollment and interim data reveal of both programs, we can look forward to results in the second half of 2016,” stated David Hall, CEO. “The design of both trials is to provide safety, clinically relevant, and quantitative biologic data to support licensing discussions while demonstrating the further potential for expanding medical indications for our NBDS platform.”
The study is projected to include 30 participants, male and female. Participants will be selected based on their health status, current/past medications and ability to adhere to protocol-related requirements. After providing informed consent at the first visit, participants will be evaluated against the study inclusion/exclusion criteria and will provide blood samples for screening assessments. If suitable for participation, a biopsy will be taken from the scalp from which RSC-01 will be prepared, and four treatment evaluation sites will be identified on the buttocks — two on each side. Participants will be randomized into one of two treatment groups; one will receive injections of RCS-01 or placebo or a ‘sham’ injection (a needle penetration without injection of liquid) while the other (placebo group) will only receive placebo or a ‘sham’ injection. The primary purpose of this study is to assess the safety profile of RCS-01 injections compared to placebo injections. The study will also measure the impact RCS-01 injections have on skin markers related to aging through evaluation of gene expression profiles. This trial design is intended to deliver data related to how, and the degree in which the product injection improves the fullness of the extracellular matrix supporting the skin. This data will be critical to designing future trials intended to affect the skin’s appearance in areas of aesthetic importance.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aging skin, and pattern baldness. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company has also developed a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. Visit www.replicel.com for additional information.