Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Adipose Tissue derived MSCs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Adipose Tissue Derived MSCs Transplantation | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ASES (American Shoulder and Elbow Surgeons Evaluation form) | 24 weeks | |
| UCLA (University of California, Los Angeles) score | 24 weeks | |
| DASH (Disabilities of the Arm, Shoulder and Hand ) |
Participants should meet all the inclusion criteria. Patients must consent in writing to participate in the study by signing and dating an informed consent document approved by IRB indicating that the patient has been informed of all pertinent aspects of the study prior to completing any of the screening procedures
Inclusion Criteria:
Exclusion Criteria:
Participants who met a single condition were excluded from the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chris H. Jo, M.D., Ph.D | Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Autologous Adipose Tissue Derived MSCs Transplantation | Biological |
|
|
| Autologous Adipose Tissue Derived MSCs Transplantation | Biological |
|
|
| Visual Analog Scale_pain in motion |
| 24 weeks |
| Changes in the size of rotator cuff tears determined by MRI | 24 weeks |
| Changes in the size of rotator cuff tears determined by arthroscopy | 24 weeks |
| Adverse event | 24weeks |
| 24 weeks |
| WORC (Western Ontario Rotator Cuff Index) | 24 weeks |
| OSS (Oxford Shoulder Scores) | 24 weeks |
| SANE (Single Assessment Numeric Evaluation) | 24 weeks |
| SST (Simple Shoulder Test) | 24 weeks |
| Visual Analog Scale_pain at rest | 24 weeks |
| Visual Analog Scale_pain at night | 24 weeks |
| Visual Analog Scale_worst pain | 24 weeks |
| Visual Analog Scale_satisfaction | 24 weeks |
| Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree) | 24 weeks |
| Muscle strength (lb) | The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale | 24 weeks |
| Body weight (Kg) | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body weight | 24 weeks |
| Body temperature (℃) | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body temperature | 24 weeks |
| Pulse rate (beats per minute) | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate | 24 weeks |
| Blood Pressure (mmHg) | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure | 24 weeks |
| CBC(complete blood count) | The measures are composite. | 24 weeks |
| Blood chemistry | The measures are composite. | 24 weeks |
| Urinalysis | The measures are composite. | 24weeks |