Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Rotator Cuff Disease

Conditions
-----------------
Rotator Cuff Disease

Intervention / Treatment
-----------------
* Biological: Autologous Adipose Tissue Derived MSCs Transplantation
* Biological: Autologous Adipose Tissue Derived MSCs Transplantation
* Biological: Autologous Adipose Tissue Derived MSCs Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Male or female 19 years of age and older. Patients who have unilateral shoulder pain. Patients who have had pain at least for 3 months and do not respond to conservative treatment. Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US). Exclusion Criteria: Participants who met a single condition were excluded from the study Patients who received any drug by subacromial injection for treatment within 3 months prior to this enrollment. Patients who have a history of shoulder trauma including dislocation, subluxation, and fracture, breast cancer, or surgery around shoulder, neck and upper back within 6 months prior to this enrollment. Patients who have a full-thickness rotator cuff tear Patients who have radiological findings of malignancy, osteoarthritis of the glenohumeral joint, and skeletal abnormalities decreasing the subacromial space Patients with symptomatic cervical spine disorders Patients with concurrent bilateral shoulder pain Patients with adhesive capsulitis, acromioclavicular arthropathy, polyarthritis, infectious arthritis, rheumatoid arthritis or diagnosed fibromyalgia Patients with neurological deficit Pregnant women or lactating mothers Fertile woman of childbearing potential not willing to use adequate contraception for the study duration Patients taking anticoagulants Patients who are positive serology for human immunodeficiency (HIV), hepatitis B (HBV) or hepatitis C (HCV) and syphilis Patients with serious condition which can affect this study such as severe cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, and cancers Patients who are difficulty participating in data collection due to communication problem and serious mental illness Patients are unable to come into the clinic for regular follow-up Patients who had participated in other clinical trials within 3 months prior to this study. Patients who the principal investigator considered inappropriate for the clinical trial due to any other reasons than those listed above.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Adipose Tissue derived MSCs<br> | Biological: Autologous Adipose Tissue Derived MSCs Transplantation<br>* Study drugs: Autologous adipose tissue derived MSCs Injection dosage and volume of the study drugs: Low dose: 1x10e7 cells/3mL Number of injections : only once during the study period Device: Ultrasound Injection technique: Injection into the lesion by investigator<br>Biological: Autologous Adipose Tissue Derived MSCs Transplantation<br>* Study drugs: Autologous adipose tissue derived MSCs Injection dosage and volume of the study drugs: Mid dose: 5x10e7 cells/3mL Number of injections : only once during the study period Device: Ultrasound Injection technique: Injection into the lesion by investigator<br>Biological: Autologous Adipose Tissue Derived MSCs Transplantation<br>* Study drugs: Autologous adipose tissue derived MSCs Injection dosage and volume of the study drugs: High dose: 1x10e8 cells/3mL Number of injections : only once during the study period Device: Ultrasound Injection technique: Injection into the lesion by investigator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |