Clinical trial NCT02655042: Long-Term Follow-up of the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
Official title: A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tendinosis
Tendinopathy
Lead sponsor: RepliCel Life Sciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syreon Corporation
First posted: 2016-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 24 months post-injection
Secondary outcomes:
measure: Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
timeFrame: 24 months post-injection
measure: Modified Tegner Activity Scale
timeFrame: 24 months post-injection
measure: SF-36 questionnaire
timeFrame: 24 months post-injection
measure: Tendon condition (appearance)
timeFrame: 24 months post-injection
measure: Tendon condition (blood flow)
timeFrame: 24 months post-injection
measure: Tendon condition (fibrillar pattern)
timeFrame: 24 months post-injection
measure: Tendon condition (presence of abnormalities)
timeFrame: 24 months post-injection
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Alan McGavin Sports Medicine Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: D R Lloyd-Smith, MDCM
role: PRINCIPAL_INVESTIGATOR
References: