A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear (NCT06414005) | Clinical Trial Compass
RecruitingPhase 2/3
A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear
South Korea166 participantsStarted 2024-04-15
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Be 19 years of age or older.
✓. Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI.
✓. Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment
✓. VAS pain score ≥4 at screening.
✓. Understand fully the study and voluntarily sign the informed consent for participation in the study.
Exclusion criteria
✕. Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI.
✕. Have been treated with the following
✕. Have been diagnosed with the following diseases.
✕. Have allergies to bovine proteins or gentamicin.
✕. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.