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

Tego Science, Inc.2 sites in 1 country93 target enrollmentJuly 9, 2018

ConditionsRotator Cuff Injuries

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rotator Cuff Injuries
Sponsor: Tego Science, Inc.
Enrollment: 93
Locations: 2
Primary Endpoint: Retear Rate
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 9, 2018

End Date

April 28, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tego Science, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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