Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease

Seoul National University

Status: Completed

Conditions: Rotator Cuff Disease

Treatments: Biological: Autologous Adipose Tissue Derived MSCs Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02474342

BRM-15-01

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Autologous Adipose Tissue derived MSCs

Experimental group

Treatment:

Biological: Autologous Adipose Tissue Derived MSCs Transplantation

Biological: Autologous Adipose Tissue Derived MSCs Transplantation

Biological: Autologous Adipose Tissue Derived MSCs Transplantation