None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Subjects undergo arthroscopic rotator cuff repair with or without autologous fibroblasts.
Sponsors
Tego Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retear rate assessed an by independent evaluator with MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of ROM (Range of Motion);Changes of functional scores (Constant Score, ASES pain score and SST) | — |
Countries
Korea, Republic of
Contacts
Public ContactJooHan Oh
Seoul National University Bundang Hospital
Outcome results
None listed