TendinosisReaCT-XNCT02655042
Long-Term Follow-up of the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
An observational study of Tendinosis and Tendinopathy, run by RepliCel Life Sciences, Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Tendinosis, Tendinopathy
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who have completed participation in a clinical trial to evaluate the safety and efficacy of injections of RCT-01.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alan McGavin Sports Medicine Centre
Vancouver, British Columbia, V6T 1Z3
About this study
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
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
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months post-injection
Secondary outcomes (7)
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
pain on palpation and pain on loading (running/jumping)
Measured: 24 months post-injection
Modified Tegner Activity Scale
Measured: 24 months post-injection
SF-36 questionnaire
quality of life questionnaire
Measured: 24 months post-injection
Tendon condition (appearance)
Ultrasound imaging will be utilized to measure region and relative location (from calcaneus) of damage and overall tendon size (in mm)
Measured: 24 months post-injection
Tendon condition (blood flow)
Ultrasound imaging will be utilized to measure blood flow (vascularization) within the tendon. Defined on ordinal scale
Measured: 24 months post-injection
Tendon condition (fibrillar pattern)
Fibrillar pattern observed during ultrasound imaging of tendon structure will be graded on ordinal scale.
Measured: 24 months post-injection
Tendon condition (presence of abnormalities)
Presence/absence of intratentinous calcification, observable tears, and irregularities in calcaneus bone structure will be noted during ultrasound imaging.
Measured: 24 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: Study conduct does not meet corporate objectives of sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RepliCel Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syreon Corporation
- Responsible party
- Sponsor
- Investigators
- D R Lloyd-Smith, MDCM, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655042
- Sponsor's protocol ID
- RCT-01-002-2015
- Acronym
- ReaCT-X
- Status last verified
- Apr 2016
- First submitted
- 5 Jan 2016
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02655042
- Acronym / sponsor ID
- ReaCT-X / RCT-01-002-2015
- Conditions
- Tendinosis, Tendinopathy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study conduct does not meet corporate objectives of sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RepliCel Life Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syreon Corporation
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have completed participation in a clinical trial to evaluate the safety and efficacy of injections of RCT-01.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse events
Time frame: 24 months post-injection
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.
7 secondary outcomes
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
Time frame: 24 months post-injection
Modified Tegner Activity Scale
Time frame: 24 months post-injection
SF-36 questionnaire
Time frame: 24 months post-injection
Tendon condition (appearance)
Time frame: 24 months post-injection
Tendon condition (blood flow)
Time frame: 24 months post-injection
Tendon condition (fibrillar pattern)
Time frame: 24 months post-injection
Tendon condition (presence of abnormalities)
Time frame: 24 months post-injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- RepliCel Corporate WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D R Lloyd-Smith, MDCM principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendinosis and Tendinopathy, run by RepliCel Life Sciences, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 24 months post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.