A Phase 1/2 interventional study of RCT-01 and Placebo in Tendinosis and Tendinopathy, sponsored by RepliCel Life Sciences, Inc.. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by RepliCel Life Sciences, Inc. · Phase 1/2, Interventional, and Treatment
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.
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →RepliCel Life Sciences, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cultured, autologous hair follicle cells suspended in cryomedium
Drug: RCT-01
cryomedium
Drug: Placebo
Incidence of adverse events
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.
Time frame: 6 months post-injection
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
Time frame: 6 months post-injection
Visual analog scale (VAS)
pain on palpation and pain on loading (running/jumping)
Time frame: 6 months post-injection
Modified Tegner Activity Scale
Time frame: 6 months post-injection
SF-36 questionnaire
quality of life questionnaire
Time frame: 6 months post-injection
Tendon condition (appearance, biomechanics, and blood flow)
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
Time frame: 6 months post-injection
This study is terminated, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
RepliCel Life Sciences, Inc.