Long-Term Follow-up of the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis (ReaCT-X)

A Long-term Follow-up 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 long-term safety profile of RCT-01 injections as compared to placebo injections. This study will also measure the long-term impact these injections will have on tendon structure and function and the symptoms of Achilles tendinosis.

This is study is designed to follow participants who have completed participation in a clinical trial where they received injections of either RCT-01 or placebo in the Achilles tendon. No clinical interventions will be performed as part of study procedures.

The day of study entry (Visit 1) will be coordinated with the participant's final visit in the earlier clinical trial. All participants will return to the clinic for repeat assessments of their Achilles tendinosis and overall health 6, 12 and 18 months after study entry. Furthermore, they will complete 'telephone visits'; during which they will report information on their overall health; 3, 9, and 15 months after study entry. Total duration of patient participation is approximately 18 months.

Study Overview

• Status: Withdrawn
• Conditions: Tendinopathy; Tendinosis

• Study Type: Observational

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • Alan McGavin Sports Medicine Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals who have completed participation in a clinical trial to evaluate the safety and efficacy of injections of RCT-01.

Description

Inclusion Criteria:

• Participation in a clinical trial designed to evaluate RCT-01 treatment for chronic Achilles tendinosis. Participants must complete the final study visit in the earlier trial prior to participation in this clinical trial.
• Willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol.

Exclusion Criteria:

• The presence of any condition that, in the investigator's opinion would impact participant safety and/or a participant's ability to complete all study related procedures. (e.g., psychiatric illness, drug addiction, alcoholism, etc.)

NOTE: age limits not specifically set in this trial as entry into current trial based on qualification/completion of previous clinical trial where age rage of participants was explicitly stated.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
RCT-01; Participants in previous clinical trial that received blinded injection of RCT-01
Placebo; Participants in previous clinical trial that received blinded injection of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire	pain on palpation and pain on loading (running/jumping)	24 months post-injection
Modified Tegner Activity Scale		24 months post-injection
SF-36 questionnaire	quality of life questionnaire	24 months post-injection
Tendon condition (appearance)	Ultrasound imaging will be utilized to measure region and relative location (from calcaneus) of damage and overall tendon size (in mm)	24 months post-injection
Tendon condition (blood flow)	Ultrasound imaging will be utilized to measure blood flow (vascularization) within the tendon. Defined on ordinal scale	24 months post-injection
Tendon condition (fibrillar pattern)	Fibrillar pattern observed during ultrasound imaging of tendon structure will be graded on ordinal scale.	24 months post-injection
Tendon condition (presence of abnormalities)	Presence/absence of intratentinous calcification, observable tears, and irregularities in calcaneus bone structure will be noted during ultrasound imaging.	24 months post-injection

Collaborators and Investigators

• Sponsor: RepliCel Life Sciences, Inc.
• Collaborators: Syreon Corporation

Publications and helpful links

Helpful Links

• RepliCel Corporate Website

Study record dates

Study Major Dates

• Primary Completion (ANTICIPATED): August 1, 2018
• Study Completion (ANTICIPATED): August 1, 2018

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 11, 2016
• First Posted (ESTIMATE): January 13, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: RCT-01-002-2015