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

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 had painkiller within 1 week prior to screening visit.
• Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
• Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
• Have shoulder surgery on the rotator cuff tear or had received drug that included growth factor, within 6 months 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.