NCT02474342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

July 7, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2016

Completed
Last Updated

March 7, 2017

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

June 2, 2015

Last Update Submit

March 6, 2017

Conditions

Rotator Cuff Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Constant-Murley score

    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 Outcomes (20)

  • 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

  • +17 more other outcomes

Study Arms (1)

Autologous Adipose Tissue derived MSCs

EXPERIMENTAL
Biological: Autologous Adipose Tissue Derived MSCs Transplantation

Interventions

Autologous Adipose Tissue Derived MSCs TransplantationBIOLOGICAL

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

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 19 years of age and older.
  • Patients who have unilateral shoulder pain.
  • Patients who have had pain at least for 3 months and do not respond to conservative treatment.
  • Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).

You may not qualify if:

  • Participants who met a single condition were excluded from the study
  • Patients who received any drug by subacromial injection for treatment within 3 months prior to this enrollment.
  • 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.
  • Patients who have a full-thickness rotator cuff tear
  • Patients who have radiological findings of malignancy, osteoarthritis of the glenohumeral joint, and skeletal abnormalities decreasing the subacromial space
  • Patients with symptomatic cervical spine disorders
  • Patients with concurrent bilateral shoulder pain
  • Patients with adhesive capsulitis, acromioclavicular arthropathy, polyarthritis, infectious arthritis, rheumatoid arthritis or diagnosed fibromyalgia
  • Patients with neurological deficit
  • Pregnant women or lactating mothers
  • Fertile woman of childbearing potential not willing to use adequate contraception for the study duration
  • Patients taking anticoagulants
  • Patients who are positive serology for human immunodeficiency (HIV), hepatitis B (HBV) or hepatitis C (HCV) and syphilis
  • Patients with serious condition which can affect this study such as severe cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, and cancers
  • Patients who are difficulty participating in data collection due to communication problem and serious mental illness
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

Study Officials

  • Chris H. Jo, M.D., Ph.D

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, SMG-SNU Boramae Medical Center

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 17, 2015

Study Start

July 7, 2015

Primary Completion

November 1, 2016

Study Completion

November 7, 2016

Last Updated

March 7, 2017

Record last verified: 2016-05

Locations

KR(1)