Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis (ReaCT)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Incidence of adverse events [ Time Frame: 6 months post-injection ]Comparison of the safety profile between RCT-01/placebo treatment groups. The safety profile is defined by the incidence, relationship to treatment, severity and seriousness of adverse events.
- Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire [ Time Frame: 6 months post-injection ]
- Visual analog scale (VAS) [ Time Frame: 6 months post-injection ]pain on palpation and pain on loading (running/jumping)
- Modified Tegner Activity Scale [ Time Frame: 6 months post-injection ]
- SF-36 questionnaire [ Time Frame: 6 months post-injection ]quality of life questionnaire
- Tendon condition (appearance, biomechanics, and blood flow) [ Time Frame: 6 months post-injection ]Ultrasound imaging will be utilized to measure: echogenicity, hyperemia or neovascularisation, anechoic regions/intratendinous tears, intratendinous calcification, any irregularities to the cortical bone at insertion, and tendon thickness
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||April 2017|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Cultured, autologous hair follicle cells suspended in cryomedium
Placebo Comparator: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT02330146
|Canada, British Columbia|
|Allan McGavin Sports Medicine Centre|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Principal Investigator:||D R Lloyd-Smith, MDCM||University of British Columbia|