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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02655042
Other study ID # RCT-01-002-2015
Secondary ID
Status Withdrawn
Phase N/A
First received January 5, 2016
Last updated April 6, 2016
Est. completion date August 2018

Study information

Verified date April 2016
Source RepliCel Life Sciences, Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 66 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Alan McGavin Sports Medicine Centre Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
RepliCel Life Sciences, Inc. Syreon Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire pain on palpation and pain on loading (running/jumping) 24 months post-injection No
Secondary Modified Tegner Activity Scale 24 months post-injection No
Secondary SF-36 questionnaire quality of life questionnaire 24 months post-injection No
Secondary 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 Yes
Secondary 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 Yes
Secondary Tendon condition (fibrillar pattern) Fibrillar pattern observed during ultrasound imaging of tendon structure will be graded on ordinal scale. 24 months post-injection Yes
Secondary 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 Yes
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