Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis (ReaCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02330146
Recruitment Status : Terminated (
  • slower than anticipated rate of enrollment
  • need to obtain safety and efficacy data in a timely manner
  • pending expiry of manufacturing materials/reagents
)
First Posted : January 1, 2015
Last Update Posted : September 28, 2017
Sponsor:
Collaborators:
Syreon Corporation
Innovacell Biotechnologie AG
Information provided by (Responsible Party):
RepliCel Life Sciences, Inc.

Tracking Information
First Submitted Date  ICMJE December 12, 2014
First Posted Date  ICMJE January 1, 2015
Last Update Posted Date September 28, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
  • 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 ]
    pain on palpation and pain on loading (running/jumping)
  • Modified Tegner Activity Scale [ Time Frame: 6 months post-injection ]
  • SF-36 questionnaire [ Time Frame: 6 months post-injection ]
    quality of life questionnaire
  • Tendon condition (appearance, biomechanics, and blood flow) [ Time Frame: 6 months post-injection ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
Official Title  ICMJE 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
Brief 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.

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tendinosis
  • Tendinopathy
Intervention  ICMJE
  • Drug: RCT-01
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: RCT-01
    Cultured, autologous hair follicle cells suspended in cryomedium
    Intervention: Drug: RCT-01
  • Placebo Comparator: Placebo
    cryomedium
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 14, 2016)
8
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2014)
28
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Participant confirmation of symptoms of unilateral chronic Achilles tendinosis for at least 6 months
  3. Completion of at least three months of physiotherapy for treatment of Achilles tendinosis at the study tendon as directed by a certified physiotherapist.
  4. VISA-A score of less than 70 at Visit S1.
  5. Willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol.
  6. Fluent understanding of written and spoken English language
  7. 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.

Exclusion Criteria:

  1. 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.
  2. History of Achilles tendon surgery (either tendon)
  3. Presence of enthesopathy or insertional tendinopathy in any tendons of the lower extremity, including Achilles tendons.
  4. Presence of any medical condition that influences lower extremity function (e.g. osteoarthritis, presence of any peripheral nerve involvement, etc.)
  5. 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.
  6. 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.)
  7. Infection with hepatitis B or C, human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV) or syphilis
  8. Participants diagnosed with cancer with or without chemotherapy treatment
  9. Women who are pregnant or nursing
  10. Ongoing or recent (within the previous 6 months) participation in a clinical research study.
  11. Participants diagnosed having uncontrolled systemic diseases
  12. Use of any medications not permitted in the study (see Excluded Medications)
  13. 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
  14. Unresolved litigation or insurance claims (e.g., Workers Compensation, WorkSafe BC, etc.) involving the Achilles tendinopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02330146
Other Study ID Numbers  ICMJE RCT-01-001-2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RepliCel Life Sciences, Inc.
Study Sponsor  ICMJE RepliCel Life Sciences, Inc.
Collaborators  ICMJE
  • Syreon Corporation
  • Innovacell Biotechnologie AG
Investigators  ICMJE
Principal Investigator: D R Lloyd-Smith, MDCM University of British Columbia
PRS Account RepliCel Life Sciences, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP