Rotator Cuff Disease
Conditions
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.
Interventions
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
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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: 1. Male or female 19 years of age and older. 2. Patients who have unilateral shoulder pain. 3. Patients who have had pain at least for 3 months and do not respond to conservative treatment. 4. 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 1. Patients who received any drug by subacromial injection for treatment within 3 months prior to this enrollment. 2. 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. 3. Patients who have a full-thickness rotator cuff tear 4. Patients who have radiological findings of malignancy, osteoarthritis of the glenohumeral joint, and skeletal abnormalities decreasing the subacromial space 5. Patients with symptomatic cervical spine disorders 6. Patients with concurrent bilateral shoulder pain 7. Patients with adhesive capsulitis, acromioclavicular arthropathy, polyarthritis, infectious arthritis, rheumatoid arthritis or diagnosed fibromyalgia 8. Patients with neurological deficit 9. Pregnant women or lactating mothers 10. Fertile woman of childbearing potential not willing to use adequate contraception for the study duration 11. Patients taking anticoagulants 12. Patients who are positive serology for human immunodeficiency (HIV), hepatitis B (HBV) or hepatitis C (HCV) and syphilis 13. Patients with serious condition which can affect this study such as severe cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, and cancers 14. Patients who are difficulty participating in data collection due to communication problem and serious mental illness 15. Patients are unable to come into the clinic for regular follow-up 16. Patients who had participated in other clinical trials within 3 months prior to this study. 17. Patients who the principal investigator considered inappropriate for the clinical trial due to any other reasons than those listed above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SPADI(Shoulder pain and disability index)Score | 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley score | 24 weeks | 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_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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | 24 weeks | The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale |
| ASES (American Shoulder and Elbow Surgeons Evaluation form) | 24 weeks | — |
| Body temperature (℃) | 24 weeks | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body temperature |
| Pulse rate (beats per minute) | 24 weeks | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate |
| Blood Pressure (mmHg) | 24 weeks | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure |
| CBC(complete blood count) | 24 weeks | The measures are composite. |
| Blood chemistry | 24 weeks | The measures are composite. |
| Urinalysis | 24weeks | The measures are composite. |
| Body weight (Kg) | 24 weeks | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body weight |
| UCLA (University of California, Los Angeles) score | 24 weeks | — |
| DASH (Disabilities of the Arm, Shoulder and Hand ) | 24 weeks | — |
| WORC (Western Ontario Rotator Cuff Index) | 24 weeks | — |
| OSS (Oxford Shoulder Scores) | 24 weeks | — |
| SANE (Single Assessment Numeric Evaluation) | 24 weeks | — |
Countries
South Korea
Outcome results
None listed