Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease

March 6, 2017 updated by: Hyunchul Jo, Seoul National University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Autologous Adipose Tissue derived MSCs
Biological: 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
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SPADI(Shoulder pain and disability index)Score
Time Frame: 24 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Constant-Murley score
Time Frame: 24 weeks
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
Time Frame: 24 weeks
24 weeks
Changes in the size of rotator cuff tears determined by MRI
Time Frame: 24 weeks
24 weeks
Changes in the size of rotator cuff tears determined by arthroscopy
Time Frame: 24 weeks
24 weeks
Adverse event
Time Frame: 24weeks
24weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ASES (American Shoulder and Elbow Surgeons Evaluation form)
Time Frame: 24 weeks
24 weeks
UCLA (University of California, Los Angeles) score
Time Frame: 24 weeks
24 weeks
DASH (Disabilities of the Arm, Shoulder and Hand )
Time Frame: 24 weeks
24 weeks
WORC (Western Ontario Rotator Cuff Index)
Time Frame: 24 weeks
24 weeks
OSS (Oxford Shoulder Scores)
Time Frame: 24 weeks
24 weeks
SANE (Single Assessment Numeric Evaluation)
Time Frame: 24 weeks
24 weeks
SST (Simple Shoulder Test)
Time Frame: 24 weeks
24 weeks
Visual Analog Scale_pain at rest
Time Frame: 24 weeks
24 weeks
Visual Analog Scale_pain at night
Time Frame: 24 weeks
24 weeks
Visual Analog Scale_worst pain
Time Frame: 24 weeks
24 weeks
Visual Analog Scale_satisfaction
Time Frame: 24 weeks
24 weeks
Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)
Time Frame: 24 weeks
24 weeks
Muscle strength (lb)
Time Frame: 24 weeks
The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale
24 weeks
Body weight (Kg)
Time Frame: 24 weeks
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body weight
24 weeks
Body temperature (℃)
Time Frame: 24 weeks
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body temperature
24 weeks
Pulse rate (beats per minute)
Time Frame: 24 weeks
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate
24 weeks
Blood Pressure (mmHg)
Time Frame: 24 weeks
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure
24 weeks
CBC(complete blood count)
Time Frame: 24 weeks
The measures are composite.
24 weeks
Blood chemistry
Time Frame: 24 weeks
The measures are composite.
24 weeks
Urinalysis
Time Frame: 24weeks
The measures are composite.
24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BRM-15-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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