NBDS Fibroblast Therapy – Treatment for Chronic Tendinosis
RCT-01 Development Status
RCT-01 is an autologous cell-based treatment utilizing non-bulbar dermal sheath (NBDS) cells isolated from the hair follicle sheath to treat chronic tendinosis caused by acute and chronic tensile overuse. The company 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.
Watch our video to learn more about RepliCel’s RCT-01 treatment for chronic tendinosis.
Official Trial Title: Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
RepliCel’s Phase 1/2 trial will focus on the use of NBDS cells isolated from the hair follicle sheath. The trial will enroll 28 subjects whom have failed traditional tendon treatments and whom are otherwise in good health. NBDS cells will be isolated from a small punch biopsy taken from the back of the scalp. These cells will be replicated and then reintroduced into the wounds within the tendon via ultrasound. After injections are performed, 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.
RCT-01 Trial Design
- Secondary endpoint – efficacy at 6 months
- Function, pain, tendon appearance & biomechanics, blood flow, activity scale, quality of life measurements at 1, 2, 4 and 6 months
- Treatment: fibroblast cells from hair follicle sheath
- Abundant, healthy and easily accessible
- Prolific producers of type I collagen