Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease

Rotator Cuff Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474342
• Other study ID #: BRM-15-01
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: March 6, 2017
• Start date: July 7, 2015
• Est. completion date: November 7, 2016

Study information

• Verified date: May 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 7, 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Disease

Intervention

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
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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