RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that it has received approval from the University of British Columbia (UBC) Clinical Research Ethics Board (CREB) to conduct a phase 1/2 clinical trial at the UBC Hospital.
The trial, entitled, “A randomized, double-blind, placebo-controlled, single-centre study to evaluate the efficacy and safety of RCT-01 in men and women with unilateral, chronic Achilles tendinosis” (also known as the “ReaCT study”), will investigate the potential of RepliCel’s tendon repair product, RCT-01, to treat chronic tendon injury. CREB approval clears the way for site initiation and patient recruitment into the clinical trial.
The ReaCT study will be led by an affiliated researcher, Dr. Rob Lloyd-Smith, with the Vancouver Coastal Health Research Institute (VCHRI). “VCHRI is very pleased to be supporting biotechnology in British Columbia and play a role in the development of a potential technology in cell therapy,” says Dr. Robert McMaster, Executive Director of VCHRI and Vice-President of Research with Vancouver Coastal Health.
The study will include 28 participants with chronic Achilles tendinosis. Study participants will receive ultrasound-guided injections of either RCT-01 or placebo (on a 3:1 treatment-to-placebo ratio) directly into areas of injury within the Achilles tendon. Participants’ overall health and tendinosis will be monitored over a six month period while they undergo post-treatment physiotherapy to help facilitate recovery from their Achilles tendinosis.
“I am very excited to be involved in this world-class study investigating the use of RepliCel’s autologous cell therapy for the treatment of chronic tendinosis,” stated Jack Taunton, MD, Professor Emeritus Faculty of Medicine, Division of Sports Medicine at the University of British Columbia and Director Sports Medicine at Fortius Sport & Health, acting in the capacity of clinical trial medical monitor. “For several decades, I have been proud to be part of a group of clinicians in Vancouver conducting cutting-edge research looking for better ways to treat patients with various tendinopathies. We believe cell therapy – and in particular hair-derived fibroblasts which are highly expressive of type 1 collagen – represents a promising approach to treating these patients and generating better, quicker, and longer-lasting outcomes than current treatment options. While patients will be followed-up for longer periods, by early 2016 we expect to have data giving us a clear indication of the potential for this treatment to regenerate tendon in ways currently not possible.”
“With UBC CREB approval, we can immediately take the steps needed to open this trial to patient recruitment and treatment. This is an important milestone in management’s plan to create significant value in the company through mid-2016,” stated Darrell Panich, Vice President of Clinical Affairs for RepliCel.
RCT-01 is the first of two products from RepliCel’s non-bulbar dermal sheath (NBDS) fibroblast platform currently slated to be tested in clinical trials in 2015. Subject to regulatory clearance, the second product, RCS-01, will be evaluated as a potential treatment for aged and UV-damaged skin. The company filed an application to conduct a phase 1 clinical trial of RCS-01 with the German competent regulatory authority on February 23, 2015 and is now awaiting clearance. RepliCel’s NBDS fibroblast program is a broad platform that has the potential to extend into other indications characterized by impaired tissue healing and a deficit of type 1 collagen.
RepliCel is actively targeting commercialization partners for both of these products, particularly in Asian markets at this time. The company owns all rights to these product candidates and is in active prosecution of a full spectrum of intellectual property protection around key aspects of the cell source, manufacturing, use and composition of matter.
