Overview

This trial is active, not recruiting.

Condition rotator cuff disease
Treatments autologous adipose tissue derived mscs transplantation
Sponsor Seoul National University Hospital
Start date July 2015
End date September 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
Masking open label
Primary purpose treatment
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

Male or female participants at least 19 years old.

Inclusion Criteria: 1. Age>19 , males and females. 2. Unilateral shoulder pain 3. Symptomatic for > 3M, 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, adhesive 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.

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 July 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.