The purpose of this study is to evaluate safety and efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
1. Study drugs: Autologous adipose tissue derived MSCs 2. Injection dosage and volume of the study drugs: * Low dose: 1x10e7 cells/3mL 3. Number of injections : only once during the study period 4. Device: Ultrasound 5. Injection technique: Injection into the lesion by investigator
1. Study drugs: Autologous adipose tissue derived MSCs 2. Injection dosage and volume of the study drugs: * Mid dose: 5x10e7 cells/3mL 3. Number of injections : only once during the study period 4. Device: Ultrasound 5. Injection technique: Injection into the lesion by investigator
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, South Korea
SPADI(Shoulder pain and disability index)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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
Visual Analog Scale_pain in motion
Time frame: 24 weeks
Changes in the size of rotator cuff tears determined by MRI
Time frame: 24 weeks
Changes in the size of rotator cuff tears determined by arthroscopy
Time frame: 24 weeks
Adverse event
Time frame: 24weeks
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1. Study drugs: Autologous adipose tissue derived MSCs 2. Injection dosage and volume of the study drugs: * High dose: 1x10e8 cells/3mL 3. Number of injections : only once during the study period 4. Device: Ultrasound 5. Injection technique: Injection into the lesion by investigator