A Multi-center, Randomized, Independent Evaluator-Subject Blinded, Placebo-Controlled, Phase I/III Clinical Study to Evaluate Safety and Efficacy of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0003174
- Lead Sponsor
- Tego Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 93
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Retear rate assessed an by independent evaluator with MRI
- Secondary Outcome Measures
Name Time Method Change of ROM (Range of Motion);Changes of functional scores (Constant Score, ASES pain score and SST)