Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients with Rotator Cuff Disease

Phase 1

Recruiting

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

• Registration Number: NCT06794294
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study Start: 2025-01-17
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-27
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Male or female 19 years of age and older.
• Patients with unilateral shoulder pain lasting for at least 3months
• Patients who do not respond to conservative treatment.
• Patients who have not responded to sufficient non-surgical treatments, including medication, injection therapy, physical therapy, or exercise therapy, for more than 3 months
• Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).
• Patients without any restrictions on clinical trial procedures, including hospitalization.

Exclusion Criteria

• Patients who have received subacromial injection therapy on the affected shoulder within the past 3 months.
• Patients who have undergone rotator cuff surgery on the affected shoulder within the past 6 months
• Patients with a history of receiving stem cell therapy for the shoulder.
• Patients with the following shoulder conditions: complete rotator cuff tear, adhesive capsulitis, or isolated acromioclavicular joint arthropathy.
• Patients showing or suspected of having the following radiological findings: malignancy, severe osteoarthritis of the glenohumeral joint, or skeletal abnormalities decreasing the subacromial space.
• Patients presenting with symptomatic cervical spine disorders.
• Patients with concurrent bilateral shoulder pain
• Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.
• Patients with neurological deficit
• Pregnant women or lactating mothers.
• Patients unwilling to use effective contraception during the clinical trial period.
• Patients with current HBV, HCV, or HIV infections, or those with a positive RPR test.
• Patients with severe diseases that may affect the clinical trial, including cardiovascular disease, renal disease, liver disease, endocrine disorders, or malignancies.
• Patients who are unable to understand the questionnaires used for assessing their clinical status, including the Visual Analogue Scale (VAS), or those with psychiatric disorders impairing communication.
• Patients who do not wish to participate in the clinical trial or are unable to comply with follow-up schedules.
• Patients who have participated in another clinical trial within the last 3 months.
• Patients deemed unsuitable for participation in this clinical trial at the investigator's discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with partial-thickness rotator cuff tear	Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell	-

Primary Outcome Measures

Name	Time	Method
Shoulder pain and disability index(SPADI) Score	6 months	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The minimum value is 0 and the maximum value is 10. "0" means no pain and "10" means the worst pain imaginable in the pain section. "0" means no difficulty and "10" means so difficult it requires help in the pain section.

Secondary Outcome Measures

Name	Time	Method
Changes in the size of rotator cuff tears determined by MRI	6 months
Changes in the size of rotator cuff tears determined by arthroscopy	6 months
Constant-Murley score	6 months	The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
Visual Analog Scale(VAS) pain in motion	6 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.
Adverse event	6 months

Trial Locations

Locations (1)

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Korea, Republic of