RepliCel Life Sciences (OTC:REPCF) touted data this week from its Phase 1/2 tendon repair study evaluating its type I collagen-expressing, hair follicle-derived fibroblasts as a treatment for Achilles tendinosis.
The clinical trial established a complete safety profile for RepliCel’s RCT-01 at 6 months and showed no serious adverse events related to the treatment or injection procedure.
All of the treated patients showed clinically relevant improvements in tendon composition, blood supply, physical function and pain sensation after receiving the company’s therapy.
“Chronic tendinosis is a state of tendon degeneration that is very difficult to reverse, as evidenced by the many therapies used to try and treat it,” orthopedic surgeon Dr. Ross Davidson said in prepared remarks.” This study shows exciting clinical improvements in patients with clinically diagnosed chronic Achilles tendinosis who were unresponsive to standard treatments, and who had suffered for many months (in some cases, years) with frequent pain and loss of function. Not only did the study show several clinically important improvements in pain and function scores, but several ultrasound measures clearly demonstrate a marked improvement in tendon structure; something rarely seen in patients with this condition.”
“With further clinical studies, this new technology could represent a cutting-edge advancement in kick-starting a healing process that results in tendon regeneration. For the first time, we may have a treatment that shows signs of reversing the underlying problem, versus just treating the symptoms. This could be a game-changer in sports medicine.”
“This trial was to show the safety of injection of hair follicle-derived non-bulbar dermal sheath cells (NBDS), as well as to repeat the landmark trials of our collaborators who injected skin-derived fibroblasts together with PRP (platelet-rich plasma) in different tendinopathies,” RepliCel’s chief medical officer Dr. Rolf Hoffman added. “We believe the cause of healing (mechanism of action) in those studies was the cellular collagen production and not the PRP which, in our view, has little clinical or commercial potential as a therapeutic product or treatment for tendon repair.”
“I am very pleased that in this trial we see some early signals of regenerative healing in some patients and because of its similar pathogenesis, there is every reason to believe the ability to heal Achilles tendons will extend to numerous applications including repairing the patellar tendon of the knee (jumper’s knee), both tendons of elbow (tennis elbow, golfer’s elbow), and the rotator cuff. Furthermore, when we have established that our cell therapy heals chronic tendon injury, it may then be used by physicians for more acute injury with the goal of an approved label for these additional treatments in the future.”
“This is a major step forward in the Company’s development of a series of products which leverage the exciting collagen-producing capacity of these cells,” CEO Lee Buckler said. “Our management and clinical team are very excited about the data from this trial and the potential for further development and clinical testing of this product to treat patients without good options for the tendon degeneration, pain and loss of function they are experiencing. We have captured the medical and investment communities’ attention and see the results of this much anticipated, proof-of-concept clinical study as an opportunity to advance therapies for patients and incrementally add value for shareholders in the months ahead.”
REPCF shares were trading at 66¢ apiece in afternoon trading activity, up 13%.