NCT02474342CompletedNot Applicable
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Rotator Cuff Disease
Seoul National University Hospital1 site in 1 country18 target enrollmentStarted: July 7, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- SPADI(Shoulder pain and disability index)Score
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
SPADI(Shoulder pain and disability index)Score
Time Frame: 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 Outcomes
- Visual Analog Scale_pain in motion(24 weeks)
- Constant-Murley score(24 weeks)
- Adverse event(24weeks)
- Changes in the size of rotator cuff tears determined by arthroscopy(24 weeks)
- Changes in the size of rotator cuff tears determined by MRI(24 weeks)
Investigators
Hyunchul Jo
Associate Professor, SMG-SNU Boramae Medical Center
Seoul National University Hospital
Study Sites (1)
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