NCT03668028

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Tego Science, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Injuries

Interventions

Type	Name	Description
BIOLOGICAL	TPX-114	Subjects will be treated with autologous fibroblasts (TPX-114) during arthroscopic surgery.
PROCEDURE	Arthroscopic surgery	Subjects undergo conventional arthroscopic surgery for rotator cuff repair.

Timeline

• Start date: 2018-07-09
• Primary completion: 2021-09-27
• Completion: 2022-04-28
• First posted: 2018-09-12
• Last updated: 2023-05-18

Locations

2 sites across 1 country: South Korea