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
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 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.
Single group
Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell
Biological/VaccineBiological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Low dose: 1x10⁷ cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Mid dose: 5x10⁷ cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * High dose: 1x10e8 cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator
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 in motion
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.
Changes in the size of rotator cuff tears determined by MRI
Changes in the size of rotator cuff tears determined by arthroscopy
Change in degeneration score compared to baseline and the rate of change through histological examination
When tendon regeneration is identified in the lesion area through arthroscopic examination, a tissue sample approximately 2 mm in diameter is collected from the regenerated site and evaluated using the modified Astrom \& Movin scoring system. The evaluation method consists of seven assessment variables(Fiber structure, Fiber arrangement, Rounding of the nuclei, Variations in cellularity, Increased vascularity, Decreased stainability, Hyalinization), each scored on a scale from 0 to 3, with 0 indicating normal and 3 representing the most severe abnormality. The scores are summed to calculate the tendon degeneration score, which ranges from 0 to 21. A score closer to 0 indicates normal tendon condition, while a score closer to 21 reflects severe degenerative changes.
STR (Short tandem repeat) analysis
STR analysis at post-injection
Visual Analog Scale_pain at night
Visual Analog Scale(VAS) worst 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.
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