Clinical Trial

Efficacy and Safety Study of TPX-115 on Partial-thickness Rotator Cuff Tear

Recruiting Phase 2
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Summary
The goal of this study is to evaluate the efficacy and safety of allogeneic dermal fibroblasts (TPX-115) compared to placebo in patients with Partial-Thickness Rotator Cuff Tear(PTRCT). Primary endpoint is to evaluate the efficacy of TPX-115 compared to placebo, as measured by improvement in the Constant-Murley Score (CMS) in patients with PTRCT. Secondary endpoints are: * To evaluate functional (including shoulder pain) and structural improvements in the affected shoulder after administration of TPX-115 compared to placebo in patients with PTRCT * To evaluate the safety and tolerability of TPX-115 in patients with PTRCT * To assess the immunogenicity of TPX-115
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-10-20; most recent amendment 2026-06-16.
Status change: Not Yet Recruiting → Recruiting 2026-06-16
Trial Details
NCT Number NCT07219654
Lead Sponsor Tego Science, Inc.
Conditions Partial Thickness Rotator Cuff Tears
Enrollment 60 participants
Start Date 2026-06-09
Primary Completion 2027-05 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-18