A Phase 2b3 Study Evaluating TPX-115 Injection for Partial-Thickness Rotator Cuff Tear Treatment

What this Trial Is About

Partial-thickness rotator cuff tear is a common shoulder condition where tears involve 50% or less of the tendon thickness. This trial evaluates the safety and effectiveness of an investigational treatment called TPX-115, which consists of allogeneic fibroblasts injected into the tendon. The study aims to improve tendon repair beyond standard conservative treatments by measuring shoulder function and pain scores over time. Participants are randomly assigned to receive either TPX-115 or a placebo injection guided by ultrasound directly into the tendon. The study is double-blinded, meaning neither participants nor researchers know which treatment is given. Assessments occur at 4, 12, 24, and 52 weeks after injection, with structural evaluations using MRI at 24 and 52 weeks to monitor tendon changes. During the study, participants will complete various shoulder function tests including the Constant Score, pain assessments using Visual Analogue Scale, and other shoulder-specific questionnaires. Range of motion and MRI scans will also be performed to observe physical and structural changes. The primary outcome is the change in Constant Score at 24 weeks, with ongoing safety and efficacy monitoring through one year of follow-up.

A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear