NCT07219654

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

A Phase 2, Double-blinded, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Allogeneic Dermal Fibroblasts (TPX-115) in Patients With Partial-thickness Rotator Cuff Tear

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tego Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Partial Thickness Rotator Cuff Tears

Interventions

Type	Name	Description
BIOLOGICAL	TPX-115	Single injection of Allogeneic dermal fibroblasts (TPX-115) via ultrasound-guided intratendinous injection
OTHER	Cryopreserving hyaluronic acid medium	Medium included in TPX-115 for cryopreservation
DRUG	Saline	Saline

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-05-01
• Completion: 2027-11-01
• First posted: 2025-10-22
• Last updated: 2025-10-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study