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

Rotator Cuff Injuries Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03668028
Study type Interventional
Source Tego Science, Inc.
Contact
Status Completed
Phase Phase 3
Start date July 9, 2018
Completion date April 28, 2022
View Details
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