David Hall, CEO of RepliCel, said, “CCRM represents one of the leading global entities in the area of regenerative medicine and being part of its industry consortium embeds us in an exemplary network. Their broad industry activities and, in particular, their regulatory services are an important current asset to RepliCel. Furthermore, RepliCel is pursuing CCRM as a secondary manufacturing site for the company’s fibroblast platform, which is a key step in demonstrating technology transfer, as well as risk mitigation away from a single site cell replication model.”
CCRM currently is engaged in providing RepliCel with contract regulatory services including documentation and filings related to RepliCel’s RCT-A-01 product for chronic Achilles tendinosis. This program is the subject of a planned clinical trial in Canada to start in 2014 that will involve clinical testing to address chronic tendinosis, a degenerative disease of the tendon caused by a cycle of injury, improper healing and re-injury until there are very few pain free and functional periods. Despite the body’s attempts to heal itself, complete healing of the tendon is never achieved, potentially due to a deficit of type I producing fibroblast cells needed to support the healing process.
RCT-A-01 will attempt to address this cellular deficit by providing an injection of a patient’s own fibroblasts to the site of the injury. Collagen-producing fibroblast cells will be isolated from hair follicles taken by a punch biopsy from the back of the patient’s scalp. These cells will then be grown in controlled processes. The new cells are injected directly into the wounds within the tendon via ultra-sound imaging. After injections are performed, patients return to the clinic for assessments of safety, function and pain, as well as changes in tendon thickness, echo texture, interstitial tears and neovascularity (growth of new blood vessels).
This treatment is designed to provide the necessary number of fibroblast cells to initiate and complete the disrupted healing process leading to a normally functioning tendon with higher tensile strength. Further indications will include patellar tendinosis, or jumper’s knee, and lateral elbow tendinosis.
