Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears
Arthroscopic Rotator Cuff Repair with Umbilical Cord-derived Mesenchymal Stem Cells for Large to Massive Rotator Cuff Tears
Korea University Anam Hospital
15 participants
Jan 17, 2025
INTERVENTIONAL
Conditions
Summary
Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears
Eligibility
Inclusion Criteria4
- Male or female 19 years of age and older
- Unilateral shoulder pain with a pain score of 4 or higher.
- patients with a symptom duration of at least three months who have not responded to conventional treatments, including analgesics.
- patients diagnosed with massive or extensive full-thickness rotator cuff tears confirmed by computed tomography arthrography or magnetic resonance imaging.
Exclusion Criteria14
- patients diagnosed with small or medium full-thickness rotator cuff tears among study participants with full-thickness rotator cuff tears.
- patients who have received subacromial injection therapy in the affected shoulder within the past three months.
- patients who have undergone rotator cuff surgery on the affected shoulder within the past six months.
- patients exhibiting or suspected of having the following radiological findings: malignant tumors, severe glenohumeral osteoarthritis, or bony abnormalities causing subacromial space narrowing.
- patients presenting with symptomatic cervical spine disorders.
- patients experiencing bilateral shoulder pain.
- patients diagnosed with multiple arthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.
- patients with neurological deficits.
- Pregnant or breastfeeding patients
- patients unwilling to use effective contraception during the study period.
- patients currently infected with HBV, HCV, or HIV, or those with a positive RPR test result.
- patients with severe conditions that may affect the study, including cardiovascular diseases, renal diseases, hepatic diseases, endocrine disorders, or malignancies.
- patients who are unable to comprehend the questionnaires used for study assessments, including the Visual Analog Scale (VAS), or those with communication difficulties due to psychiatric disorders.
- Any other cases deemed inappropriate for study participation by the investigator.
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Interventions
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Low dose: 2.5X10 cells/0.5mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: \- High dose: 5X10 cells/1mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator
Locations(1)
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NCT06817616