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

NCT06414005 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2024-06-05

No results posted yet for this study

Summary

Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change in Constant Score (CS) at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in CS, Visual Analogue Score (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH), Simple Shoulder Test (SST), and functional evaluations including Range of Motion (ROM) at 4, 12, 24 and 52 weeks after administration and structural evaluation using MRI at 24 and 52 weeks after injection.

Conditions

  • Partial Thickness Rotator Cuff Tear

Interventions

BIOLOGICAL

TPX-115

Ultrasound-guided intratendinous injection of allogeneic fibroblasts (TPX-115)

OTHER

Placebo (Saline)

Ultrasound-guided intratendinous placebo injection

Sponsors & Collaborators

  • Tego Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Joo Han Oh, M.D. · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2026-06-30
Completion
2027-01-31

Countries

  • South Korea

Study Locations

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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 NCT06414005 on ClinicalTrials.gov