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Starting soon Not applicable

Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears

NCT07605559 · tracked via the Priya Life Science South Korea tracker
Sponsor
Kyoung Hwan Koh
Phase
Not applicable
Started
2026-05-01
Last updated
2026-05-26

Condition(s) studied

Rotator Cuff Disease

Investigational drug(s) / intervention(s)

umbilical cord-derived mesenchymal stem cellNormal Saline

umbilical cord-derived mesenchymal stem cell: Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells

Normal Saline: Administration of normal saline as a placebo control.

Study summary

The purpose of this study is to evaluate umbilical cord-derived mesenchymal stem cell injectables for the regeneration of partial-thickness rotator cuff tears

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged 19 years or older * Shoulder pain lasting for at least 3 months * A pain visual analogue scale (VAS) score of 4 or greater * Inadequate response to sufficient conservative treatment for at least 3 months, such as medication, injection therapy, physical therapy, or exercise therapy * Partial-thickness rotator cuff tear confirmed by ultrasonography or magnetic resonance imaging (MRI) * No restrictions on participation in clinical trial procedures, including hospitalization Exclusion Criteria: * Receipt of subacromial injection therapy in the affected shoulder within the past 3 months * History of rotator cuff surgery on the affected shoulder within the past 6 months * Previous treatment with a stem cell therapy for the shoulder * Presence of any of the following shoulder conditions: full-thickness rotator cuff tear, obvious isolated acromioclavicular joint arthropathy, or a clear history of trauma to the shoulder joint within the past 3 months * Radiologic findings suggestive of or consistent with any of the following: malignancy, severe glenohumeral osteoarthritis, bony abnormalities causing narrowing of the subacromial space, or clear evidence of acute traumatic rotator cuff injury * Presence of symptomatic cervical spine disease * Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia * Clinical trial subjects with neurological deficits * Pregnant or breastfeeding women * Unwillingness to use an effective method of contraception during participation in the clinical trial * Presence of any serious disease that may affect participation in this clinical trial, including cardiovascular, renal, hepatic, endocrine, or neoplastic disease * Inability to understand the questions used to assess the subject's condition, including the visual analogue scale (VAS), or communication difficulties due to psychiatric illness * Unwillingness to participate in the clinical trial or difficulty in complying with follow-up visits according to the study schedule * Participation in another clinical trial within 3 months prior to enrollment in this clinical trial * Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial

Primary outcome measure(s)

  • Changes in the size of rotator cuff tears determined by MRI — 6months
    The location, width (AP size), length (ML size), and depth of the rotator cuff tear will be measured on oblique coronal, axial, and sagittal MRI images where the tear is most clearly visualized. The same measurements will be performed on the corresponding planes after administration of the investigational product and compared with those obtained before administration.

Trial sites (1)

FacilityCityRegionStatus
Asan Medical Center Seoul Seoul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07605559 on ClinicalTrials.gov ↗ ← All trials in South Korea