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

NCT02655042 | Withdrawn

• 1 other identifier: RCT-01-002-2015
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinosis; Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire

  24 months post-injection

• Modified Tegner Activity Scale

  24 months post-injection

• SF-36 questionnaire

  24 months post-injection

• Tendon condition (appearance)

  24 months post-injection

• Tendon condition (blood flow)

  24 months post-injection

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RepliCel Life Sciences, Inc.: lead
• Syreon Corporation: collaborator

Study Sites (1)

Alan McGavin Sports Medicine Centre

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Links

• RepliCel Corporate Website

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• D R Lloyd-Smith, MDCM

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 13, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 7, 2016

Record last verified: 2016-04

Locations

CA (1)