Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear

Inclusion criteria

Participants must;

• Be 19 years of age or older.
• Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade I, II assessed by MRI.
• Have unilateral shoulder pain lasting more than 3 months despite conservative treatment and VAS pain score ≥5 at screening.
• 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;

• Have partial-thickness rotator cuff tear larger than 50% of tendon thickness or of Ellman grade III, or full-thickness rotator cuff tear confirmed by MRI.
• Have prior medical history of shoulder surgery on the torn rotator cuff or the upper part of shoulder within 6 months prior to screening visit (shoulder trauma, fracture, upper cervical spine surgery, etc.).
• Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
• Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
• Have been diagnosed with the following diseases.

• Inflammatory joint diseases
• Other shoulder diseases which may cause shoulder pain or functional disorder
• Autoimmune diseases
• Active hepatitis B or C
• HIV Ab positive
• Malignant tumors within the last 5 years
• Coagulopathy
• Genetic disorders related to fibroblasts of collagen
• Other serious diseases deemed to affect the results of the study
• Have allergies to bovine proteins or gentamicin.
• Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
• Have participated in other clinical trials and received investigational agents within 4 weeks of this study
• Be deemed inadequate for the study by investigators.