The purpose of this study is to evaluate umbilical cord-derived mesenchymal stem cell injectables for the regeneration of partial-thickness rotator cuff tears
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
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
Parallel
umbilical cord-derived mesenchymal stem cell
Biological/VaccineAdministration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
Normal Saline
DrugAdministration of normal saline as a placebo control.
Changes in the size of rotator cuff tears determined by MRI
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.
Shoulder pain and disability index(SPADI) Score
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.
Constant-Murley score
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
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.
Location and size of the rotator cuff tear assessed by arthroscopy
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Kyoung Hwan Koh
Lead sponsor
Asan Medical Center
Sponsor institution
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