Tendinopathy Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
The primary purpose of this study is to assess the safety profile of RCT-01 injections as
compared to placebo injections. This study will also measure the impact these injections will
have on tendon structure and function and the symptoms of Achilles tendinosis.
28 participants will be selected for this study based on their health status, current/past
medications, and ability to adhere to protocol-related requirements. Prior to entering the
screening phase of the study, all potential study participants will have had to have at least
3 months of therapy for their unilateral, chronic (symptoms >6 months) Achilles tendinosis
directed by a certified physiotherapist without a clinical response. At the first visit and
after providing informed consent participants are evaluated against the study
inclusion/exclusion criteria and provide blood samples for screening assessments (including
virology). If suitable for study participation, participants will provide a biopsy from the
scalp from which RCT-01 will be prepared.
Baseline evaluations of participants' overall health and tendinosis, in particular, will be
performed on the day of injection. Once all baseline assessments have been completed, the
tendon to be treated will be anesthetized and will receive ultrasound-guided injections of
either placebo (cryomedium) or RCT-01.
All participants will return to the clinic for repeat assessments of their unilateral
Achilles tendinosis and overall health at seven (7) visits over the following 6 months.
Participants will also complete an eccentric training physiotherapy program under the
guidance of a certified physiotherapist for two (2) months after receipt of injections. Total
duration of patient participation is approximately eight (8) months.
n/a
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