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NOT YET RECRUITING
NCT07219654
PHASE2

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

Sponsor: Tego Science, Inc.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-11

Completion Date

2027-11

Last Updated

2025-10-23

Healthy Volunteers

No

Interventions

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

Locations (3)

BioSolutions Clinical Research Center

La Mesa, California, United States

Sports & Orthopedic Center - Advanced Research

Deerfield Beach, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States