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

Tendinopathy Clinical Trial

— ReaCT-X  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02655042
• Other study ID #: RCT-01-002-2015
• Status: Withdrawn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• Status: Withdrawn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

• Tendinopathy
• Tendinosis

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

External Links

•   RepliCel Corporate Website