RCT-01: Tendon Repair
In 2017, RepliCel completed a phase 1 human clinical trial of RCT-01 in patients with a chronically injured Achilles tendon. The study proved the product’s safety and provided very promising indications of the product’s potential efficacy in restoring patient function, pain and activity levels in addition to impacting measures tendon blood flow and structure.
We are currently working with our orthopedic advisors to finalize the design of a phase 2 clinical study to evaluate the product’s ability to accomplish for tendon problems what nothing else can do for some patients – notably regenerate degenerated tendon tissue to get eliminate patient pain and get patients back to doing what they love.
RepliCel intend to commence phase 2 clinical trial of RCT-01 in Japan as soon as it obtains clearance to do so from the Japanese regulatory agency (the PMDA) in 2020. If you are interested in signing up to stay informed or to possibly participate in this trial (should it be located near you), please sign up here.
FAQs About RCT-01
In short, we are not yet in a position to adequately predict this. RepliCel recently completed phase 1 human clinical trials of all its products currently in development, including RCT-01.
In most countries, it takes completing at least three phases of clinical trials to obtain approval to market a product. There are some exceptions to this general rule. For instance, Japan has created rules by which certain cell therapies may be commercially launched much faster than is the case in most countries.
We are working with our partners to explore opportunities to bring RCT-01 to market as soon as possible in certain countries. Stay tuned!