MedTrace Logo

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

NCT07219654 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Tego Science, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-05-31
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07219654 on ClinicalTrials.gov