Clinical trial NCT02474342: Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease
Official title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Rotator Cuff Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: SPADI(Shoulder pain and disability index)Score
timeFrame: 24 weeks
Secondary outcomes:
measure: Constant-Murley score
timeFrame: 24 weeks
measure: Visual Analog Scale_pain in motion
timeFrame: 24 weeks
measure: Changes in the size of rotator cuff tears determined by MRI
timeFrame: 24 weeks
measure: Changes in the size of rotator cuff tears determined by arthroscopy
timeFrame: 24 weeks
measure: Adverse event
timeFrame: 24weeks
Other outcomes:
measure: ASES (American Shoulder and Elbow Surgeons Evaluation form)
timeFrame: 24 weeks
measure: UCLA (University of California, Los Angeles) score
timeFrame: 24 weeks
measure: DASH (Disabilities of the Arm, Shoulder and Hand )
timeFrame: 24 weeks
measure: WORC (Western Ontario Rotator Cuff Index)
timeFrame: 24 weeks
measure: OSS (Oxford Shoulder Scores)
timeFrame: 24 weeks
measure: SANE (Single Assessment Numeric Evaluation)
timeFrame: 24 weeks
measure: SST (Simple Shoulder Test)
timeFrame: 24 weeks
measure: Visual Analog Scale_pain at rest
timeFrame: 24 weeks
measure: Visual Analog Scale_pain at night
timeFrame: 24 weeks
measure: Visual Analog Scale_worst pain
timeFrame: 24 weeks
measure: Visual Analog Scale_satisfaction
timeFrame: 24 weeks
measure: Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)
timeFrame: 24 weeks
measure: Muscle strength (lb)
timeFrame: 24 weeks
measure: Body weight (Kg)
timeFrame: 24 weeks
measure: Body temperature (℃)
timeFrame: 24 weeks
measure: Pulse rate (beats per minute)
timeFrame: 24 weeks
measure: Blood Pressure (mmHg)
timeFrame: 24 weeks
measure: CBC(complete blood count)
timeFrame: 24 weeks
measure: Blood chemistry
timeFrame: 24 weeks
measure: Urinalysis
timeFrame: 24weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Study officials:
affiliation: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
name: Chris H. Jo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: