A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear

Inclusion criteria

Participants must;

• 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

Participants with any of the following conditions will be excluded unless stated otherwise;

• Unsuitable for skin biopsy.
• Have additional subscapularis tear.
• Have prior medical history of the following at the time of screening.

• Operation of the affected shoulder
• Allergies to bovine proteins
• Anaphylaxis to gentamicin
• Coagulopathy
• Genetic disorders affecting fibroblasts or collagen (ex. achondroplasia, osteogenesis imperfecta)
• Malignant tumors within the last 5 years
• Have been diagnosed with any of the following diseases at the time of screening.

• Autoimmune disease (including RA)
• HIV Ab-positive
• Acute trauma, chronic shoulder dislocation, pyogenic infection on the affected shoulder
• Scapulohumeral osteoarthritis
• Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptives suggested in this study.
• Other surgical or nonsurgical procedures on the affected shoulder to be judged more appropriate than arthroscopic repair.
• Have participated in and received investigational agents in other clinical trials within 4 weeks of this study.
• Be deemed inadequate for the study by investigators.