Six-month results from Phase I/II study indicate that RepliCel's RCT-01 fibroblasts demonstrated product safety and clinical potential for tendon regeneration and healing, with no adverse events.
All treated participants, all of whom suffered chronic tendon pain and loss of function over an extended period with no response to standard treatment, showed numerous clinically-important improvements in tendon composition, blood supply, physical function and pain sensation.
RepliCel Life Sciences received approval in 2Q15 to conduct the randomized, double-blind, placebo-controlled, single-center study in Canada, evaluating type 1 collagen-expressing hair follicle-derived fibroblasts as a treatment for Achilles tendinosis.
Clinically material improvements observed include:
Clinically relevant signals of healing, with an overall 15.3% improvement in total score vs. baseline and two subjects showing select measures of near-complete recovery in function.
Three of five subjects treated with RCT-01 who completed questionnaires at six months showed improvement in pain on palpation based on VAS score. Average improvement in VAS score for the three participants was 55.2% over baseline VAS score, and two showed select measures of near-complete elimination of pain.
Additional information on the ReaCT trial is available at clinicaltrials.gov.
Sources: RepliCel Life Sciences Inc.; ORTHOWORLD Inc.