CClinicalTrials.gg
TerminatedNCT02330146ReaCTUpdated Sep 28, 2017

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

A Phase 1/2 interventional study of RCT-01 and Placebo in Tendinosis and Tendinopathy, sponsored by RepliCel Life Sciences, Inc.. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-28.

Sponsored by RepliCel Life Sciences, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
* slower than anticipated rate of enrollment * need to obtain safety and efficacy data in a timely manner * pending expiry of manufacturing materials/reagents
Phase
Phase 1/2
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tendinosis
  • Tendinopathy

Browse trials for

03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 8 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

RepliCel Life Sciences, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    RCT-01

    Cultured, autologous hair follicle cells suspended in cryomedium

    Drug: RCT-01

  • Placebo comparator
    Placebo

    cryomedium

    Drug: Placebo

Interventions

  • DrugRCT-01
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months post-injection

Secondary outcomes

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

    Time frame: 6 months post-injection

  2. Visual analog scale (VAS)

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

    Time frame: 6 months post-injection

  3. Modified Tegner Activity Scale

    Time frame: 6 months post-injection

  4. SF-36 questionnaire

    quality of life questionnaire

    Time frame: 6 months post-injection

  5. 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

    Time frame: 6 months post-injection

07

Study locations

1 site
  • Allan McGavin Sports Medicine Centre
    Vancouver, British Columbia V6T 1Z3, Canada
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02330146
Lead sponsor
RepliCel Life Sciences, Inc.
Collaborators
Syreon Corporation, Innovacell Biotechnologie AG
Responsible party
Sponsor
First posted
Jan 1, 2015
Start date
May 2015
Primary completion
Dec 2016
Completion
Jun 2017
Last update
Sep 28, 2017

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion