Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease

NCT ID: NCT02474342

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-07
• Study Completion Date: 2016-11-07

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.

Conditions

Rotator Cuff Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Adipose Tissue derived MSCs

Group Type: EXPERIMENTAL

Autologous Adipose Tissue Derived MSCs Transplantation

Intervention Type: BIOLOGICAL

1. Study drugs: Autologous adipose tissue derived MSCs

2. Injection dosage and volume of the study drugs:

• Low dose: 1x10e7 cells/3mL

3. Number of injections : only once during the study period

4. Device: Ultrasound

5. Injection technique: Injection into the lesion by investigator

Autologous Adipose Tissue Derived MSCs Transplantation

Intervention Type: BIOLOGICAL

1. Study drugs: Autologous adipose tissue derived MSCs

2. Injection dosage and volume of the study drugs:

• Mid dose: 5x10e7 cells/3mL

3. Number of injections : only once during the study period

4. Device: Ultrasound

5. Injection technique: Injection into the lesion by investigator

Autologous Adipose Tissue Derived MSCs Transplantation

Intervention Type: BIOLOGICAL

1. Study drugs: Autologous adipose tissue derived MSCs

2. Injection dosage and volume of the study drugs:

• High dose: 1x10e8 cells/3mL

3. Number of injections : only once during the study period

4. Device: Ultrasound

5. Injection technique: Injection into the lesion by investigator

Interventions

Autologous Adipose Tissue Derived MSCs Transplantation

1. Study drugs: Autologous adipose tissue derived MSCs

2. Injection dosage and volume of the study drugs:

• Low dose: 1x10e7 cells/3mL

3. Number of injections : only once during the study period

4. Device: Ultrasound

5. Injection technique: Injection into the lesion by investigator

Intervention Type: BIOLOGICAL

Autologous Adipose Tissue Derived MSCs Transplantation

1. Study drugs: Autologous adipose tissue derived MSCs

2. Injection dosage and volume of the study drugs:

• Mid dose: 5x10e7 cells/3mL

3. Number of injections : only once during the study period

4. Device: Ultrasound

5. Injection technique: Injection into the lesion by investigator

Intervention Type: BIOLOGICAL

Autologous Adipose Tissue Derived MSCs Transplantation

1. Study drugs: Autologous adipose tissue derived MSCs

2. Injection dosage and volume of the study drugs:

• High dose: 1x10e8 cells/3mL

3. Number of injections : only once during the study period

4. Device: Ultrasound

5. Injection technique: Injection into the lesion by investigator

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyunchul Jo

Associate Professor, SMG-SNU Boramae Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris H. Jo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BRM-15-01

Identifier Type: -

Identifier Source: org_study_id