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Completed

NCT Number: NCT02474342

Autologous Adipose Tissue Derived Mesenchymal Stem Cells for 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Exclusion criteria

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
  • Patients are unable to come into the clinic for regular follow-up
  • Patients who had participated in other clinical trials within 3 months prior to this study.
  • Patients who the principal investigator considered inappropriate for the clinical trial due to any other reasons than those listed above.

Treatment and study plan

Autologous Adipose Tissue Derived MSCs Transplantation

Biological
  • 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Visual Analog Scale_pain in motion

    Time frame: 24 weeks

  3. Changes in the size of rotator cuff tears determined by MRI

    Time frame: 24 weeks

  4. Changes in the size of rotator cuff tears determined by arthroscopy

    Time frame: 24 weeks

  5. Adverse event

    Time frame: 24weeks

Other outcomes

  1. ASES (American Shoulder and Elbow Surgeons Evaluation form)

    Time frame: 24 weeks

  2. UCLA (University of California, Los Angeles) score

    Time frame: 24 weeks

  3. DASH (Disabilities of the Arm, Shoulder and Hand )

    Time frame: 24 weeks

  4. WORC (Western Ontario Rotator Cuff Index)

    Time frame: 24 weeks

  5. OSS (Oxford Shoulder Scores)

    Time frame: 24 weeks

  6. SANE (Single Assessment Numeric Evaluation)

    Time frame: 24 weeks

  7. SST (Simple Shoulder Test)

    Time frame: 24 weeks

  8. Visual Analog Scale_pain at rest

    Time frame: 24 weeks

  9. Visual Analog Scale_pain at night

    Time frame: 24 weeks

  10. Visual Analog Scale_worst pain

    Time frame: 24 weeks

  11. Visual Analog Scale_satisfaction

    Time frame: 24 weeks

  12. Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)

    Time frame: 24 weeks

  13. Muscle strength (lb)

    Time frame: 24 weeks

    The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale

  14. Body weight (Kg)

    Time frame: 24 weeks

    To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body weight

  15. Body temperature (℃)

    Time frame: 24 weeks

    To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using body temperature

  16. 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

  17. Blood Pressure (mmHg)

    Time frame: 24 weeks

    To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure

  18. CBC(complete blood count)

    Time frame: 24 weeks

    The measures are composite.

  19. Blood chemistry

    Time frame: 24 weeks

    The measures are composite.

  20. Urinalysis

    Time frame: 24weeks

    The measures are composite.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2015
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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