Overview

This trial has been completed.

Condition rotator cuff disease
Treatments autologous adipose tissue derived mscs transplantation
Sponsor Seoul National University Hospital
Start date July 2015
End date November 2016
Trial size 18 participants
Trial identifier NCT02474342, BRM-15-01

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
autologous adipose tissue derived mscs transplantation
Study drugs: Autologous adipose tissue derived MSCs Injection dosage and volume of the study drugs: Low dose: 1x10e7 cells/3mL Number of injections : only once during the study period Device: Ultrasound Injection technique: Injection into the lesion by investigator
autologous adipose tissue derived mscs transplantation
Study drugs: Autologous adipose tissue derived MSCs Injection dosage and volume of the study drugs: Mid dose: 5x10e7 cells/3mL Number of injections : only once during the study period Device: Ultrasound Injection technique: Injection into the lesion by investigator
autologous adipose tissue derived mscs transplantation
Study drugs: Autologous adipose tissue derived MSCs Injection dosage and volume of the study drugs: High dose: 1x10e8 cells/3mL Number of injections : only once during the study period Device: Ultrasound Injection technique: Injection into the lesion by investigator

Primary Outcomes

Measure
SPADI(Shoulder pain and disability index)Score
time frame: 24 weeks

Secondary Outcomes

Measure
Constant-Murley score
time frame: 24 weeks
Visual Analog Scale_pain in motion
time frame: 24 weeks
Changes in the size of rotator cuff tears determined by MRI
time frame: 24 weeks
Changes in the size of rotator cuff tears determined by arthroscopy
time frame: 24 weeks
Adverse event
time frame: 24weeks

Eligibility Criteria

All participants at least 19 years old.

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.

Additional Information

Official title Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Rotator Cuff Disease
Principal investigator Chris H. Jo, M.D., Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.