Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease

Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Rotator Cuff Disease

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 Overview

• Status: Completed
• Conditions: Rotator Cuff Disease
• Intervention / Treatment: Biological: Autologous Adipose Tissue Derived MSCs Transplantation; Biological: Autologous Adipose Tissue Derived MSCs Transplantation; Biological: Autologous Adipose Tissue Derived MSCs Transplantation

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Autologous Adipose Tissue derived MSCs

Biological: 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; Biological: 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; Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPADI(Shoulder pain and disability index)Score	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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley score	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.	24 weeks
Visual Analog Scale_pain in motion		24 weeks
Changes in the size of rotator cuff tears determined by MRI		24 weeks
Changes in the size of rotator cuff tears determined by arthroscopy		24 weeks
Adverse event		24weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES (American Shoulder and Elbow Surgeons Evaluation form)		24 weeks
UCLA (University of California, Los Angeles) score		24 weeks
DASH (Disabilities of the Arm, Shoulder and Hand )		24 weeks
WORC (Western Ontario Rotator Cuff Index)		24 weeks
OSS (Oxford Shoulder Scores)		24 weeks
SANE (Single Assessment Numeric Evaluation)		24 weeks
SST (Simple Shoulder Test)		24 weeks
Visual Analog Scale_pain at rest		24 weeks
Visual Analog Scale_pain at night		24 weeks
Visual Analog Scale_worst pain		24 weeks
Visual Analog Scale_satisfaction		24 weeks
Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)		24 weeks
Muscle strength (lb)	The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale	24 weeks
Body weight (Kg)	To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body weight	24 weeks
Body temperature (℃)	To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body temperature	24 weeks
Pulse rate (beats per minute)	To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate	24 weeks
Blood Pressure (mmHg)	To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure	24 weeks
CBC(complete blood count)	The measures are composite.	24 weeks
Blood chemistry	The measures are composite.	24 weeks
Urinalysis	The measures are composite.	24weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: July 7, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 7, 2016

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 6, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BRM-15-01