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Effect of Autologous Adipose Tissue Derived Mesenchymal Stem Cells injection in Rotator Cuff Disease

Not Applicable
Completed
Conditions
Diseases of the musculo-skeletal system and connective tissue
Registration Number
KCT0001523
Lead Sponsor
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
18
Inclusion Criteria

1. Age>19 ,males and females
2. Unilateral shoulder pain
3. Symptomatic more than three months, Do not respond to conservative treatments
4. Partial-thickness rotator cuff tears (evidenced by MR or ultrasonography)

Exclusion Criteria

1. Previous subacromial injection in past 3 months
2. History of shoulder dislocation, subluxation, fracture, breast cancer, cervical/shoulder/upper back surgery in past 6 months
3. Full-thickness rotator cuff tears, adheisive capsulitis, acromioclavicular arthropathy
4. Radiological findings: malignancy, osteoarthritis of the glenohumeral joint, skeletal abnormalities decreasing the subacromial space
5. Symptomatic cervical spine disorders
6. Concurrent bilateral shoulder pain
7. Known or suspected polyarthritis, infectious arthritis, rheumatoid arthritis or diagnosed fibromyalgia
8. Neurological deficit
9. Pregnant, breastfeeding mothers
10. Patients of the must be practicing adequate contraception for the duration participation in this study
11. Patients taking anticoagulants
12. Positive serology for HBV, HCV, HIV 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. Difficulty participating in data collection due to communication problem, serious mental illness
15. Patients consent to participate in other clinical trials in 3 months
16. Unable to come into the clinic for regular treatment over the course of the following month
17. Make a judgement inappropriate other than above causes by investigator.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Shoulder Pain And Disability Index(SPADI)
Secondary Outcome Measures
NameTimeMethod
Physical examinations, Vital signs;Clinical lab tests;Adverse events;Constant-Murley score;Visual analog scale pain in motion;Changes in the size of rotator cuff tears determined by MRI ;Changes in the size of rotator cuff tears determined by arthroscopy
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