Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears
NCT ID: NCT06817616
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-01-17
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients diagnosed with Full-Thickness Rotator Cuff Tears, Including Massive and Large Tears
Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell
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
Interventions
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Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell
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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
19 Years
ALL
No
Sponsors
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Korea University Anam Hospital
OTHER
Responsible Party
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Woong Kyo Jeong
PI
Locations
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Korea University Anamh Hospital
Seoul, Korea, South Korea
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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KUAH-25-01
Identifier Type: -
Identifier Source: org_study_id
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