RepliCel Life Sciences Inc., a biotechnology company based in Irvine, California, has reported the administration of the final injection in its phase 1 safety trial of their proprietary product RCT-01 in the treatment of patients with chronic Achilles tendinopathy.
RepliCel’s RCT-01 consists of cells taken from a patient’s own hair follicles. These “non-bulbar dermal sheath” or NBDS cell are isolated from the hair follicle sheath and expanded in culture.
In this clinical trial, the NBDS cells are used to treat patients with chronic tendinosis, a condition caused by acute and chronic tendon overuse. RepliCel has received Health Canada Clearance and UBC Ethics approval to conduct its Phase 1/2 clinical trial for the treatment of chronic Achilles tendinosis. The RCT-01 chronic Achilles tendinosis clinical research study will take place at the University of British Columbia in Vancouver, BC.
RepliCel’s Phase 1/2 trial will enroll 28 subjects, all of whom suffer from chronic tendinosis and have failed traditional tendon treatments, but are, otherwise, in good health.
NBDS cells will be isolated from a small punch biopsy taken from the back of the scalp, expanded in culture and then reintroduced into the wounded tendons under the guidance of ultrasound. After these injections, all subjects will return to the clinic for assessments of safety, function and pain, as well as changes in tendon thickness, echotexture, interstitial tears and neovascularity.
Since the last patient has been injected with their own NBDS cells, the last scheduled patient visit to collect treatment follow-up data will be in late November. All data from this trial will be assessed for clinical safety of NBDS cells and six-month efficacy. These data should be un-blinded and made available for analysis and dissemination near the end of this year. year-end.
This trial is designed to ascertain the signs of efficacy but it is simply not statistically powerful enough to draw any strong conclusions about efficacy.
“What we are looking for is a convincing signal, in at least some of the treated patients, that the product has clinically relevant outcomes in terms of restoration of function, reduction of pain, and/or regeneration of the tendon structure as measured by ultrasound imaging,” said RepliCel’s Rolf Hoffmann.
Data from this trial, will, however, inform and guide RepliCel’s product development and clinical trial strategy not only for Achilles tendinopathy but also for several other tendon repair applications including the treatment of jumper’s knee, golfer’s elbow, tennis elbow, and rotator cuff.
RCT-01 contains, largely, type 1 collagen-expressing fibroblasts derived from the hair follicle. These NBDS fibroblasts have the potential to address many clinical conditions that result from a deficiency of active fibroblast cells, which are required for tissue remodeling and repair.
NBDS fibroblast cells, isolated from healthy hair follicles, are a rich source of fibroblasts unique in their high-level expression of the necessary proteins, such as Type I collagen, which can jump-start the stalled healing cycle.
RepliCel is in the process of developing a series of products from this platform that have the potential to address large commercial markets in the areas of musculoskeletal and skin-related conditions.