Clinical Trials Logo

Clinical 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.

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02330146
Study type Interventional
Source RepliCel Life Sciences, Inc.
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date May 2015
Completion date June 2017

See also
  Status Clinical Trial Phase
Recruiting NCT03307499 - NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery N/A
Recruiting NCT02499484 - Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy N/A
Completed NCT01944150 - Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis N/A
Recruiting NCT03262181 - The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy N/A
Completed NCT03502434 - A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers Phase 1
Terminated NCT01544244 - The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis N/A
Terminated NCT02978833 - Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy Phase 4
Completed NCT03229291 - A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects Phase 1
Recruiting NCT02981394 - Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions N/A
Recruiting NCT02600910 - Natural History of Shoulder Pathology in Manual Wheelchair Users N/A
Not yet recruiting NCT01225497 - Eccentric Exercise for Chronic Mid-portion Achilles Tendinopathy N/A
Not yet recruiting NCT02775201 - Plantaris Release for Non-insertional Achilles Tendinopathy N/A
Completed NCT02417987 - High Volume Injection or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy N/A
Not yet recruiting NCT02597660 - A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy Phase 2
Recruiting NCT03425357 - Sonoelastography of the Supraspinatus Tendon N/A
Completed NCT03142971 - Shock Wave Therapy for Lateral Hip Pain, Caused by Tendon Pathology N/A
Completed NCT01652495 - Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection Phase 4
Recruiting NCT03425344 - Discriminative Validity of Strain Elastography of the Supraspinatus Tendon N/A
Recruiting NCT03090672 - Cellular & Biocellular Regenerative Therapy in Musculoskeletal Pain, Dysfunction,Degenerative or Inflammatory Disease N/A
Recruiting NCT02757664 - Clinical Trial to Evaluate the Adjuvant Effect of Shock Wave Therapy in the Insertional Achilles Tendinopathy N/A