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Trial record 1 of 1 for:    NCT02362646
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Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Annetine Gelijns, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT02362646
First received: February 9, 2015
Last updated: September 14, 2017
Last verified: September 2017
  Purpose
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.

Condition Intervention Phase
Heart Failure Cardiomyopathy Ventricular Dysfunction Biological: MPC Intramyocardial Injection Drug: Control Solution Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

Further study details as provided by Annetine Gelijns, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Functional Status [ Time Frame: up to 6 months ]
    functional status, defined by the number of temporary weans from LVAD support tolerated over the 6 months post-randomization. A successful wean is the ability to tolerate temporary weaning from LVAD support for 30 minutes without sustained symptoms of worsening heart failure. Wean failures are defined as inability to tolerate the temporary wean for 30 minutes; death; or patient too unstable, in the judgment of the primary heart failure cardiologist, to tolerate the wean attempt.

  • Number of participants with adverse events [ Time Frame: up to 12 months ]
    Safety: Incidence of the study intervention-related adverse events


Secondary Outcome Measures:
  • Physiologic Assessments [ Time Frame: up to 12 months ]
    Echocardiographic assessments of the myocardial size and function by transthoracic echocardiography with LVAD at full support, and as tolerated following 6-Minute Walk Test (MWT) while weaned from LVAD support (for patients who tolerate wean from LVAD support for 30 minutes)

  • Histopathological assessments of myocardial tissue [ Time Frame: up to 12 months ]
  • Overall Survival [ Time Frame: up to 12 months ]
  • Change in Quality of Life (QoL) [ Time Frame: 6 months and 12 months ]
    Quality of life will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a widely used tool in heart failure populations, and the Short Form 12 (SF12), a widely used overall health status measure.

  • Hopkins Verbal Learning Test [ Time Frame: 3 months and 12 months ]
    Cognitive performance will be assessed Hopkins Verbal Learning Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

  • Trailmaking Tests A and B [ Time Frame: 3 months and 12 months ]
    Cognitive performance will be assessed using Trailmaking Tests A and B. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

  • MCG Complex Figures [ Time Frame: 3 months and 12 months ]
    Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

  • Digit Span [ Time Frame: 3 months and 12 months ]
    Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

  • Digit Symbol Substitution Test [ Time Frame: 3 months and 12 months ]
    Cognitive performance will be assessed using the Digit Symbol Substitution Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

  • Controlled Oral Word Association [ Time Frame: 3 months and 12 months ]
    Cognitive performance will be assessed using the Controlled Oral Word Association. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

  • Length of Stay [ Time Frame: up to 12 months ]
    Length of stay of index hospitalization

  • Hospitalizations [ Time Frame: up to 12 months ]
    Frequency and cause of readmissions

  • Hospital Costs [ Time Frame: up to 12 months ]
    Hospital resource use

  • Functional Status [ Time Frame: up to 12 months ]
    functional status, defined by the number of temporary weans from LVAD support tolerated


Enrollment: 159
Study Start Date: July 2015
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MPC Intramyocardial Injection
Intramyocardial injections of 150 million MPCs
Biological: MPC Intramyocardial Injection
Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation
Other Names:
  • Mesenchymal Precursor Cell Injection
  • RevascorTM
Sham Comparator: Control Solution
Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
Drug: Control Solution
Other Names:
  • 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
  • Cryoprotective media

Detailed Description:
Intramyocardial injection of mesenchymal precursor cells (MPC) in patients with advanced heart failure who are treated with left ventricular assist device (LVAD) implantation may result in a renewable source of proliferating functional cardiomyocytes; induce development of capillaries and larger-size blood vessels to supply oxygen and nutrients to endogenous myocardium and newly-implanted cardiomyocytes; and release factors capable of paracrine signaling.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation

    • Age 18 years or older
    • If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure
    • Female subjects of childbearing potential must have a negative serum pregnancy test at screening
    • Admitted to the clinical center at the time of randomization
    • Clinical indication and accepted candidate for implantation of an FDA-approved (US sites only) or Health Canada-approved (Canadian sites only) implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.

Exclusion Criteria:

  • Planned percutaneous LVAD implantation

    • Anticipated requirement for biventricular mechanical support
    • Concomitant arrhythmia ablation at time of LVAD implantation

      -- Planned aortic valve intervention for aortic insufficiency at the time of LVAD implantation

    • Cardiothoracic surgery within 30 days prior to randomization
    • Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as unstable plaque rupture, erosion or dissection within 30 days prior to randomization
    • Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty
    • Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism)
    • Stroke within 30 days prior to randomization
    • Platelet count < 100,000/ul within 24 hours prior to randomization
    • Acute infectious process: acute bacterial, fungal, or viral disease OR acute exacerbation of chronic infectious disease such as hepatitis
    • Presence of >10% anti-HLA antibody titers with known specificity to MPC donor HLA antigens
    • A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products
    • History of a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated
    • Presence of human immunodeficiency virus (HIV)
    • Received investigational intervention within 30 days prior to randomization
    • Treatment and/or an incomplete follow-up treatment of any investigational cell based therapy within 6 months prior to randomization
    • Active participation in other research therapy for cardiovascular repair/regeneration
    • Prior recipient of stem precursor cell therapy for cardiac repair
    • Pregnant or breastfeeding at time of randomization.
    • History of known or suspected hypercoagulable state in the opinion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02362646

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Montefiore Einstein Heart Center
The Bronx, New York, United States, 10467
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor Research Institute
Plano, Texas, United States, 75093
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Health Systems
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53726
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Québec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Annetine Gelijns
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Patrick O'Gara, MD Brigham and Women's Hospital
Study Chair: Richard Weisel, MD Toronto General Hospital
  More Information

Additional Information:
Responsible Party: Annetine Gelijns, Chair, Department of Population Health Science & Policy; Edmond A. Guggenheim Professor of Health Policy; Co-Director, InCHOIR, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02362646     History of Changes
Other Study ID Numbers: GCO 08-1078-0008
2U01HL088942-07 ( U.S. NIH Grant/Contract )
Study First Received: February 9, 2015
Last Updated: September 14, 2017

Keywords provided by Annetine Gelijns, Icahn School of Medicine at Mount Sinai:
Heart Failure
Left Ventricular Assist Device
Heart Transplantation
Cardiomyopathy, Destination Therapy
Cell Therapy
Bridge to Transplant

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 19, 2017