Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT03668028
Eligibility Criteria:
Inclusion Criteria:
Participants must;
1. Be 19 years of age or older.
2. 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.
3. Consent to undergo skin biopsy to manufacture test product.
4. 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;
1. Unsuitable for skin biopsy.
2. Have additional subscapularis tear.
3. 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
4. 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
5. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptives suggested in this study.
6. Other surgical or nonsurgical procedures on the affected shoulder to be judged more appropriate than arthroscopic repair.
7. Have participated in and received investigational agents in other clinical trials within 4 weeks of this study.
8. Be deemed inadequate for the study by investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03668028
Study Brief:
Protocol Section:
NCT03668028