RepliCel obtains two important approvals to conduct RCS-01 phase 1 human clinical trial

RepliCel Life Sciences Inc.Jul 21 2015

German-based trial to test RCS-01 cell therapy treatment for aged and sun-damaged skin

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 two important approvals required to conduct its RCS-01 phase 1 human clinical trial. The first is from the Ethics Committee of the Faculty of Medicine Heinrich-Heine Universität Duesseldorf, a criteria for clinical trial initiation, and the second is approval from the Leibniz-Institut for its Tissue Procurement Authorization (TPA). Ethics Committee approval and TPA are two parts of a three-part Clinical Trial Application (CTA) approval process required to conduct human clinical trials in Germany. The final approval required is from the Paul Ehrlich Institute (PEI), the German regulatory body. If cleared to proceed, the proposed trial will be conducted at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany.

RepliCel's non-bulbar dermal sheath-derived fibroblast therapy entitled RCS-01 provides a promising treatment for intrinsically or extrinsically aged/damaged skin by providing UV-naïve 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 more efficient replication potential in culture. Furthermore, the proprietary culture conditions in which RCS-01 is manufactured enables these cells to maintain plasticity. This plasticity allows the cells to adapt to the microenvironment and respond to the mechanical or surrounding stimuli after injection, leading to robust production of type 1 collagen and elastin and their proper alignment within the tissue. For more information on this trial, please visit www.clinicaltrials.gov.

"The market for dermal fillers currently represented almost 6 million procedures and expenditures of almost $2 billion in 2013 according to statistics provided by the American Society of Plastic Surgeons. RCS-01 could disrupt this market by providing patients with a filler comprised of their own fibroblast cells – a much more compelling long-term solution than hyaluronic acid which dissipates in approximately six months," commented Dr. Rolf Hoffmann, Chief Medical Officer. "Successfully treating aged and sun damaged skin with our therapy would allow a patient to have a renewed dermal appearance by repopulating the patient's aged and depleted fibroblast cells which are the key cells responsible for maintaining and repairing the skin's extracellular matrix."

"These two important approvals bring us closer to initiation of our RCS-01 clinical trial. Approval from the PEI will enable us to immediately begin the recruitment phase of our trial. With the initiation of this study, we will have two clinical trials using our NBDS-fibroblasts underway; RCT-01 in Canada and RCS-01 in Germany," stated David Hall, CEO.