TendinosisPhase 1/2ReaCTNCT02330146
Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
A Phase 1/2 study testing RCT-01 in people with 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 safety profile of RCT-01 injections as compared to placebo injections. This study will also measure the 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 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendinosis, Tendinopathy
- What is being tested?
- RCT-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Jun 2017
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between the age of 18 and 65 years and in good health having evidence of mid-substance unilateral, chronic Achilles tendinosis confirmed by ultrasound imaging.
- Participant confirmation of symptoms of unilateral chronic Achilles tendinosis for at least 6 months
- Completion of at least three months of physiotherapy for treatment of Achilles tendinosis at the study tendon as directed by a certified physiotherapist.
- VISA-A score of less than 70 at Visit S1.
- Willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol.
- Fluent understanding of written and spoken English language
- Females must either be post-menopausal for at least one year, surgically sterile, or, if of childbearing potential, using highly-effective methods of birth control during the study. This method of contraception must be used at least 4 weeks prior to screening (Visit S1) and during the entire duration of the clinical trial.
Who cannot join
- Any prior therapeutic injections to the Achilles tendon to be studied (e.g., platelet-rich plasma, prolotherapy, dextrose, dry needling, etc) within 6 months of study Visit S1.
- History of Achilles tendon surgery (either tendon)
- Presence of enthesopathy or insertional tendinopathy in any tendons of the lower extremity, including Achilles tendons.
- Presence of any medical condition that influences lower extremity function (e.g. osteoarthritis, presence of any peripheral nerve involvement, etc.)
- Presence of seronegative arthropathies, diabetes mellitus (type I and II), elevated blood sugar, insertional arthropathies-psoriasis, iritis, inflammatory bowel syndrome, sacroiliitis, metabolic syndrome or positive test for human leukocyte antigen (HLA) B 27.
- 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.)
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- Infection with hepatitis B or C, human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV) or syphilis
- Participants diagnosed with cancer with or without chemotherapy treatment
- Women who are pregnant or nursing
- Ongoing or recent (within the previous 6 months) participation in a clinical research study.
- Participants diagnosed having uncontrolled systemic diseases
- Use of any medications not permitted in the study (see Excluded Medications)
- Participants currently using other active treatments for tendinosis other than physiotherapy (e.g., acupuncture, trigger point therapy, chiropractic treatments, glyceryl trinitrate patches) during study or within 3 months prior to Visit 1
- Unresolved litigation or insurance claims (e.g., Workers Compensation, WorkSafe BC, etc.) involving the Achilles tendinopathy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Allan McGavin Sports Medicine Centre
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: A Randomized, Double-blind, Placebo-controlled 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 safety profile of RCT-01 injections as compared to placebo injections. This study will also measure the impact these injections will have on tendon structure and function and the symptoms of Achilles tendinosis.
28 participants will be selected for this study based on their health status, current/past medications, and ability to adhere to protocol-related requirements. Prior to entering the screening phase of the study, all potential study participants will have had to have at least 3 months of therapy for their unilateral, chronic (symptoms >6 months) Achilles tendinosis directed by a certified physiotherapist without a clinical response. At the first visit and after providing informed consent participants are evaluated against the study inclusion/exclusion criteria and provide blood samples for screening assessments (including virology). If suitable for study participation, participants will provide a biopsy from the scalp from which RCT-01 will be prepared.
Read more
Baseline evaluations of participants' overall health and tendinosis, in particular, will be performed on the day of injection. Once all baseline assessments have been completed, the tendon to be treated will be anesthetized and will receive ultrasound-guided injections of either placebo (cryomedium) or RCT-01.
All participants will return to the clinic for repeat assessments of their unilateral Achilles tendinosis and overall health at seven (7) visits over the following 6 months. Participants will also complete an eccentric training physiotherapy program under the guidance of a certified physiotherapist for two (2) months after receipt of injections. Total duration of patient participation is approximately eight (8) months.
- Conditions
- Tendinosis, Tendinopathy
- Being tested
- RCT-01, Placebo
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCT-01Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| RCT-01 | Experimental | Cultured, autologous hair follicle cells suspended in cryomedium Receives: Drug: RCT-01 |
| Placebo | Placebo comparator | cryomedium Receives: Drug: 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: 6 months post-injection
Secondary outcomes (5)
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
Measured: 6 months post-injection
Visual analog scale (VAS)
pain on palpation and pain on loading (running/jumping)
Measured: 6 months post-injection
Modified Tegner Activity Scale
Measured: 6 months post-injection
SF-36 questionnaire
quality of life questionnaire
Measured: 6 months post-injection
Tendon condition (appearance, biomechanics, and blood flow)
Ultrasound imaging will be utilized to measure: echogenicity, hyperemia or neovascularisation, anechoic regions/intratendinous tears, intratendinous calcification, any irregularities to the cortical bone at insertion, and tendon thickness
Measured: 6 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 posted1 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionJun 2017
Why it stopped: * slower than anticipated rate of enrollment * need to obtain safety and efficacy data in a timely manner * pending expiry of manufacturing materials/reagents
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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- RepliCel Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syreon Corporation, Innovacell Biotechnologie AG
- Responsible party
- Sponsor
- Investigators
- D R Lloyd-Smith, MDCM, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330146
- Sponsor's protocol ID
- RCT-01-001-2014
- Acronym
- ReaCT
- Status last verified
- Sep 2017
- First submitted
- 12 Dec 2014
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
- ClinicalTrials.gov ID
- NCT02330146
- Acronym / sponsor ID
- ReaCT / RCT-01-001-2014
- Conditions
- Tendinosis, Tendinopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: * slower than anticipated rate of enrollment * need to obtain safety and efficacy data in a timely manner * pending expiry of manufacturing materials/reagents
- Enrolment
- 8 participants (actual)
- Lead sponsor
- RepliCel Life Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syreon Corporation, Innovacell Biotechnologie AG
- Study start
- May 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 1 Jan 2015 (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 safety profile of RCT-01 injections as compared to placebo injections. This study will also measure the impact these injections will have on tendon structure and function and the symptoms of Achilles tendinosis.
28 participants will be selected for this study based on their health status, current/past medications, and ability to adhere to protocol-related requirements. Prior to entering the screening phase of the study, all potential study participants will have had to have at least 3 months of therapy for their unilateral, chronic (symptoms >6 months) Achilles tendinosis directed by a certified physiotherapist without a clinical response. At the first visit and after providing informed consent participants are evaluated against the study inclusion/exclusion criteria and provide blood samples for screening assessments (including virology). If suitable for study participation, participants will provide a biopsy from the scalp from which RCT-01 will be prepared.
Baseline evaluations of participants' overall health and tendinosis, in particular, will be performed on the day of injection. Once all baseline assessments have been completed, the tendon to be treated will be anesthetized and will receive ultrasound-guided injections of either placebo (cryomedium) or RCT-01.
All participants will return to the clinic for repeat assessments of their unilateral Achilles tendinosis and overall health at seven (7) visits over the following 6 months. Participants will also complete an eccentric training physiotherapy program under the guidance of a certified physiotherapist for two (2) months after receipt of injections. Total duration of patient participation is approximately eight (8) months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCT-01 | Experimental | Drug: RCT-01Cultured, autologous hair follicle cells suspended in cryomedium |
| Placebo | Placebo comparator | Drug: Placebocryomedium |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female between the age of 18 and 65 years and in good health having evidence of mid-substance unilateral, chronic Achilles tendinosis confirmed by ultrasound imaging.
- Participant confirmation of symptoms of unilateral chronic Achilles tendinosis for at least 6 months
- Completion of at least three months of physiotherapy for treatment of Achilles tendinosis at the study tendon as directed by a certified physiotherapist.
- VISA-A score of less than 70 at Visit S1.
- 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 (14 listed)
- Any prior therapeutic injections to the Achilles tendon to be studied (e.g., platelet-rich plasma, prolotherapy, dextrose, dry needling, etc) within 6 months of study Visit S1.
- History of Achilles tendon surgery (either tendon)
- Presence of enthesopathy or insertional tendinopathy in any tendons of the lower extremity, including Achilles tendons.
- Presence of any medical condition that influences lower extremity function (e.g. osteoarthritis, presence of any peripheral nerve involvement, etc.)
- Presence of seronegative arthropathies, diabetes mellitus (type I and II), elevated blood sugar, insertional arthropathies-psoriasis, iritis, inflammatory bowel syndrome, sacroiliitis, metabolic syndrome or positive test for human leukocyte antigen (HLA) B 27.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RCT-01 | Drug | RCT-01 |
| Placebo | Drug | Placebo |
Primary outcome
Incidence of adverse events
Time frame: 6 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.
5 secondary outcomes
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
Time frame: 6 months post-injection
Visual analog scale (VAS)
Time frame: 6 months post-injection
Modified Tegner Activity Scale
Time frame: 6 months post-injection
SF-36 questionnaire
Time frame: 6 months post-injection
Tendon condition (appearance, biomechanics, and blood flow)
Time frame: 6 months post-injection
Results and safety
The study was stopped early (reason given: * slower than anticipated rate of enrollment * need to obtain safety and efficacy data in a timely manner * pending expiry of manufacturing materials/reagents). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- RepliCel Life Sciences, Inc. WebsiteLink provided by the sponsor.
- Study information site for potential participantsLink 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?
A Phase 1/2 study testing RCT-01 in people with 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 Sep 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: * slower than anticipated rate of enrollment * need to obtain safety and efficacy data in a timely manner * pending expiry of manufacturing materials/reagents). Results are not available in the source record.
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: 6 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 28 Sep 2017.