A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear (NCT03668028) | Clinical Trial Compass
CompletedPhase 3
A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear
South Korea93 participantsStarted 2018-07-09
Plain-language summary
Rotator cuff tear is one of the most common shoulder diseases and retears occur frequently after arthroscopic repair. Therefore, there is a growing need of new therapy to improve structural outcome. This study evaluates the efficacy and safety of autologous fibroblasts during arthroscopic repair. The primary outcome is the retear rate at 24 weeks after administration of autologous fibroblasts (TPX-114) during arthroscopic repair. Secondary outcomes are functional evaluations including Range of Motion (ROM), Constant Score (CS), American Shoulder and Elbow Surgeons (ASES) score and Simple Shoulder Test (SST) at 24 and 52 weeks after administration.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Be 19 years of age or older.
✓. Require arthroscopic repair for full-thickness rotator cuff tear(\>2cm, ≤5cm) assessed by MRI without improvement of symptoms despite more than 3 months of conservative management.
✓. Consent to undergo skin biopsy to manufacture test product.
✓. Understand fully the study and voluntarily sign the informed consent for participation in the study.
Exclusion criteria
✕. Unsuitable for skin biopsy.
✕. Have additional subscapularis tear.
✕. Have prior medical history of the following at the time of screening.
✕. Have been diagnosed with any of the following diseases at the time of screening.
✕. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptives suggested in this study.