Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears

Not Applicable

Recruiting

• Conditions: Rotator Cuff Disease
• Interventions: Biological: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

• Registration Number: NCT06817616
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-17
• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with Full-Thickness Rotator Cuff Tears, Including Massive and Large Tears	Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale(VAS) pain in motion	12 months	Using a ruler, the score is determined by measuring the distance (mm) on the 100mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
Changes in the size of rotator cuff tears determined by MRI	12 months
Adverse event	12 months

Trial Locations

Locations (2)

Korea University Anamh Hospital; 🇰🇷 Seoul, Korea, Korea, Republic of

Korea University Anamh Hospital; 🇰🇷 Seoul, Korea, Korea, Republic of