Health Canada Gives Go-Ahead for RepliCel Clinical Trial

Health Canada has granted approval for RepliCel Life Sciences Inc. will be able to begin its phase 1/2 clinical trial for RCT-01, a cell therapy product for the treatment of chronic Achilles tendonitis.

The study, titled, “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” (known as the “ReaCT” study), investigates the potential of RCT-01 to treat chronic tendon injury. The ReaCT study has been submitted to the University of British Columbia (UBC) Clinical Ethics Review Board (CREB) for its review and required approval prior to study initiation at the University of British Columbia Hospital.

The study is anticipated to include 28 participants who will receive either an injection of RCT-01 or placebo (on a 3:1 treatment-to-placebo ratio) directly into the Achilles tendon using ultrasound guided imaging. Participants’ overall health and tendinosis will be monitored over a six-month period while they undergo post-treatment therapy to help facilitate recovery from their Achilles tendinosis. Depending on the time required to enroll the study participants, the Vancouver, Canada-based regenerative medicine company anticipates this treatment follow-up period could be complete as early as the latter part of 2015.

“Health Canada’s No Objection Letter for RepliCel’s ReaCT trial within 30 days of the company’s first clinical trial application not only supports the technology, but evidences the great work done by the clinical team in terms of the trial design,” said Ross Davidson, MBChB, chair of RepliCel’s RCT-01 Clinical Advisory Board and retired clinical professor, Department of Orthopedics, UBC. “I have seen first-hand the limitations of the current standard of care for a significant percentage of chronic tendinosis patients whom remain refractory to any available treatment. The ReaCT trial marks a milestone in the advancement of regenerative medicine for the treatment of tendinosis and offers the very distinct possibility of a new treatment paradigm for this difficult and often debilitating condition. I expect this trial focused on chronic Achilles tendinosis to be the first step in addressing other debilitating tendon injuries in the future.”

“The design of this trial has benefited from contributions from an outstanding group of key opinion leaders, including our clinical advisors and principal investigators, who provided expertise on the trial’s design, implementation, and several other critical parameters,” stated David Hall, president and CEO of RepliCel. “The ReaCT trial represents an important step in the development of a series of products based on our non-bulbar dermal sheath (NBDS) fibroblast technology platform with the potential to address large commercial markets in the areas of musculoskeletal injury and disease. In conclusion, the initiation of the ReaCT trial triggers a significant series of asset-building steps over the next 18 months covering clinical and business milestones.”

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.