Actively Recruiting
Safety and Exploratory Efficacy of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cell Treatment in Rotator Cuff Disease
Led by Seoul National University Hospital · Updated on 2026-04-29
21
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and exploratory effectiveness of allogenic umbilical cord-derived mesenchymal stem cell treatment in patients with rotator cuff disease. This open-label, single-center study includes adults aged 19 years and older who have a partial-thickness rotator cuff tear confirmed by MRI or ultrasound. The study is sponsored by Seoul National University Hospital and aims to better understand treatment options for patients who have not responded to conservative therapies. Participants will receive one injection of the stem cell treatment directly into the lesion using ultrasound guidance. The study tests three different dosages: low, mid, and high doses of stem cells, each given only once during the study period. The treatment is designed to be administered by an investigator using a precise injection technique. Throughout the study, participants will undergo assessments including the Shoulder Pain and Disability Index (SPADI) score, Constant-Murley score, Visual Analog Scale (VAS) for pain during motion, and imaging evaluations using MRI and arthroscopy to track changes in the rotator cuff tear size. Safety is closely monitored by recording any adverse events over six months. Participants will be followed for this duration to evaluate treatment effects and safety outcomes.
CONDITIONS
Brief Title
Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients With Rotator Cuff Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 19 years and older
- Unilateral shoulder pain lasting at least 3 months
- No response to conservative treatment including medication, injections, physical therapy, or exercise for more than 3 months
- Partial-thickness rotator cuff tear confirmed by MRI or ultrasound
- No restrictions on clinical trial procedures including hospitalization
You will not qualify if you...
- Received subacromial injection therapy on the affected shoulder within the past 3 months
- Rotator cuff surgery on the affected shoulder within the past 6 months
- History of stem cell therapy for the shoulder
- Complete rotator cuff tear, adhesive capsulitis, or isolated acromioclavicular joint arthropathy
- Radiological findings of malignancy, severe osteoarthritis, or skeletal abnormalities reducing subacromial space
- Symptomatic cervical spine disorders
- Bilateral shoulder pain
- Polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia
- Neurological deficit
- Pregnant or lactating women
- Unwillingness to use effective contraception during the trial
- Current HBV, HCV, or HIV infection, or positive RPR test
- Severe diseases affecting the trial such as cardiovascular, renal, liver, endocrine disorders, or malignancies
- Inability to understand questionnaires or psychiatric disorders impairing communication
- Unwilling or unable to comply with follow-up schedules
- Participation in another clinical trial within the last 3 months
- Investigator's discretion deeming unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit with follow-up lasting up to 6 months
Participants receive a single injection of allogenic umbilical cord-derived mesenchymal stem cells into the rotator cuff lesion using ultrasound guidance.
1 injection visit and multiple follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, Korea, South Korea, 07061
Actively Recruiting
Research Team
K
KeeJeong Bae, Principal Investigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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