None listed
Conditions
Interventions
Drug, Biological/Vaccine, Stem Cell : 1. Product Name: AcesoStem-Teno
2. Manufacturer: AcesoStem Biostrategies Co., Ltd.
3. Formulation and Characteristics
3.1. Investigational Drug
3.2. Dosage Form:
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adults aged 19 years or older. 2. Study participants with unilateral shoulder pain with a pain score of 4 or higher. 3. Individuals with symptoms persisting for more than 3 months and not responding to conventional treatments (e.g., analgesics). 4. Individuals diagnosed with a full-thickness rotator cuff tear, classified as a massive or extensive tear, confirmed by computed tomography arthrography or magnetic resonance imaging.
Exclusion criteria
Exclusion criteria: 1. Individuals among the study participants with a full-thickness rotator cuff tear confirmed as a small or medium tear. 2. Individuals who have received subacromial injection therapy in the affected shoulder within the past 3 months. 3. Individuals who have undergone rotator cuff surgery on the affected shoulder within the past 6 months. 4. Individuals showing or suspected of having the following radiological findings: malignant tumor, severe glenohumeral osteoarthritis, or bony abnormalities causing subacromial space narrowing. 5. Individuals with symptomatic cervical spine disorders. 6. Individuals experiencing bilateral shoulder pain. 7. Study participants with multiple arthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia. 8. Study participants with a neurological deficit. 9. Pregnant or breastfeeding individuals. 10. Individuals unwilling to use effective contraception during the study period. 11. Individuals currently infected with HBV, HCV, or HIV, or those who test positive for RPR. 12. Individuals with severe conditions that may affect the study, such as cardiovascular disease, kidney disease, liver disease, endocrine disorders, or tumors. 13. Individuals who are unable to understand the questionnaires used for assessing study participant conditions, including VAS, or who have communication difficulties due to mental disorders. 14. Individuals deemed unsuitable for study participation at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examinations, Vital signs;Clinical lab tests;Local reaction at the surgical site | — |
Countries
Korea, Republic of
Contacts
Public ContactEunmi Ahn
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Outcome results
None listed