Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease

Not Applicable

Completed

• Conditions: Rotator Cuff Disease
• Interventions: Biological: Autologous Adipose Tissue Derived MSCs Transplantation

• Registration Number: NCT02474342
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-17
• Study Start: 2015-07-07
• Status Verified: 2016-05
• Primary Completion: 2016-11
• Study Completion: 2016-11-07
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Adipose Tissue derived MSCs	Autologous Adipose Tissue Derived MSCs Transplantation	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Visual Analog Scale_pain in motion	24 weeks
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.
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

Trial Locations

Locations (1)

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of