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

NCT02655042 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2016-04-07

No results posted yet for this study

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

Sponsors & Collaborators

  • Syreon Corporation

    collaborator INDUSTRY

  • RepliCel Life Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • D R Lloyd-Smith, MDCM · University of British Columbia

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655042 on ClinicalTrials.gov