Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0005436
- Lead Sponsor
- Tego Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 49
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of ASES
- Secondary Outcome Measures
Name Time Method Change of ASES;Change of VAS pain score;Change of functional outcomes;Changes of tear size and thickness on MRI assessed by an independent evaluator;Changes of tear/footprint on MRI assessed by an independent evaluator;Changes of tendinosis grade on MRI assessed by an independent evaluator