A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear

Study Overview
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Brief Summary
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Rotator cuff tear is one of the most common shoulder diseases and retears occur frequently after arthroscopic repair. Therefore, there is a growing need of new therapy to improve structural outcome. This study evaluates the efficacy and safety of autologous fibroblasts during arthroscopic repair. The primary outcome is the retear rate at 24 weeks after administration of autologous fibroblasts (TPX-114) during arthroscopic repair. Secondary outcomes are functional evaluations including Range of Motion (ROM), Constant Score (CS), American Shoulder and Elbow Surgeons (ASES) score and Simple Shoulder Test (SST) at 24 and 52 weeks after administration.

Official Title
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A Multi-center, Randomized, Independent Evaluator-Subject Blinded, Placebo-Controlled, Phase I/III Clinical Study to Evaluate Safety and Efficacy of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear

Conditions
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Rotator Cuff Injuries

Intervention / Treatment
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* Biological: TPX-114
* Procedure: Arthroscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must; Be 19 years of age or older. Require arthroscopic repair for full-thickness rotator cuff tear(>2cm, ≤5cm) assessed by MRI without improvement of symptoms despite more than 3 months of conservative management. Consent to undergo skin biopsy to manufacture test product. Understand fully the study and voluntarily sign the informed consent for participation in the study. Exclusion Criteria: Participants with any of the following conditions will be excluded unless stated otherwise; Unsuitable for skin biopsy. Have additional subscapularis tear. Have prior medical history of the following at the time of screening. Operation of the affected shoulder Allergies to bovine proteins Anaphylaxis to gentamicin Coagulopathy Genetic disorders affecting fibroblasts or collagen (ex. achondroplasia, osteogenesis imperfecta) Malignant tumors within the last 5 years Have been diagnosed with any of the following diseases at the time of screening. Autoimmune disease (including RA) HIV Ab-positive Acute trauma, chronic shoulder dislocation, pyogenic infection on the affected shoulder Scapulohumeral osteoarthritis Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptives suggested in this study. Other surgical or nonsurgical procedures on the affected shoulder to be judged more appropriate than arthroscopic repair. Have participated in and received investigational agents in other clinical trials within 4 weeks of this study. Be deemed inadequate for the study by investigators.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPX-114<br>Subjects undergo arthroscopic rotator cuff repair with TPX-114. | Biological: TPX-114<br>* Subjects will be treated with autologous fibroblasts (TPX-114) during arthroscopic surgery.<br>Procedure: Arthroscopic surgery<br>* Subjects undergo conventional arthroscopic surgery for rotator cuff repair.<br>|
| Placebo Comparator: Placebo<br>Subjects undergo arthroscopic surgery for rotator cuff repair without TPX-114. | Procedure: Arthroscopic surgery<br>* Subjects undergo conventional arthroscopic surgery for rotator cuff repair.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retear Rate | Retear rate assessed by an independent evaluator with MRI | 24 weeks |