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

Primary Purpose

Tendinosis, Tendinopathy

Status

Terminated

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

RCT-01

Placebo

About this trial

This is an interventional treatment trial for Tendinosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.)
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

Sites / Locations

Allan McGavin Sports Medicine Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RCT-01

Placebo

Arm Description

Cultured, autologous hair follicle cells suspended in cryomedium

cryomedium

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire

Visual analog scale (VAS)

pain on palpation and pain on loading (running/jumping)

Modified Tegner Activity Scale

SF-36 questionnaire

quality of life questionnaire

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

Full Information

NCT ID

NCT02330146

First Posted

December 12, 2014

Last Updated

September 26, 2017

Sponsor

RepliCel Life Sciences, Inc.

Collaborators

Syreon Corporation, Innovacell Biotechnologie AG

1. Study Identification

Unique Protocol Identification Number

NCT02330146

Brief Title

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

Acronym

ReaCT

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Terminated

Why Stopped

slower than anticipated rate of enrollment need to obtain safety and efficacy data in a timely manner pending expiry of manufacturing materials/reagents

Study Start Date

May 2015 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RepliCel Life Sciences, Inc.

Collaborators

Syreon Corporation, Innovacell Biotechnologie AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tendinosis, Tendinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RCT-01

Arm Type

Experimental

Arm Description

Cultured, autologous hair follicle cells suspended in cryomedium

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

cryomedium

Intervention Type

Drug

Intervention Name(s)

RCT-01

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Incidence of adverse events

Description

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.

Time Frame

6 months post-injection

Secondary Outcome Measure Information:

Title

Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire

Time Frame

6 months post-injection

Title

Visual analog scale (VAS)

Description

pain on palpation and pain on loading (running/jumping)

Time Frame

6 months post-injection

Title

Modified Tegner Activity Scale

Time Frame

6 months post-injection

Title

SF-36 questionnaire

Description

quality of life questionnaire

Time Frame

6 months post-injection

Title

Tendon condition (appearance, biomechanics, and blood flow)

Description

Time Frame

6 months post-injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

D R Lloyd-Smith, MDCM

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allan McGavin Sports Medicine Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T 1Z3

Country

Canada

12. IPD Sharing Statement

Links:

URL

http://www.replicel.com

Description

RepliCel Life Sciences, Inc. Website

URL

http://www.tendonstudy.com

Description

Study information site for potential participants

Learn more about this trial

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

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