Actively Recruiting

Phase 2
Phase 3
Age: 19Years +
All Genders
NCT06414005

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

Led by Tego Science, Inc. · Updated on 2024-06-05

166

Participants Needed

2

Research Sites

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 19 years of age or older.
  • Have partial-thickness rotator cuff tear involving 50% or less of tendon thickness or Ellman grade II confirmed by MRI.
  • Have unilateral shoulder pain, muscle weakness, and limited active range of motion lasting more than 3 months despite conservative treatment.
  • Have a Visual Analogue Score (VAS) pain score of 4 or higher at screening.
  • Understand the study fully and voluntarily sign informed consent to participate.
Not Eligible

You will not qualify if you...

  • Have full-thickness rotator cuff tear confirmed by MRI.
  • Have taken painkillers within 1 week before the screening visit.
  • Have used systemic steroids or immunosuppressive agents within 4 weeks before the screening visit.
  • Have received subacromial or intra-articular injections in the affected shoulder within 3 months before the screening visit.
  • Have had shoulder surgery on the rotator cuff or received drugs containing growth factors within 6 months before the screening visit.
  • Have inflammatory joint diseases.
  • Have other shoulder diseases causing pain or functional issues.
  • Have autoimmune diseases.
  • Have active hepatitis B or C.
  • Are HIV antibody positive.
  • Have had malignant tumors within the last 5 years.
  • Have coagulopathy.
  • Have genetic disorders related to fibroblasts or collagen.
  • Have other serious diseases affecting study results.
  • Are allergic to bovine proteins or gentamicin.
  • Are pregnant, breastfeeding, planning pregnancy, or unwilling to use contraception as suggested.
  • Have participated in other clinical trials or received investigational agents within 4 weeks.
  • Are deemed unsuitable for the study by investigators.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

2

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

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Research Team

J

Jikhyon Han, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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