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Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Icahn School of Medicine at Mount Sinai
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: February 17, 2017
Last verified: February 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: 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 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


Estimated Enrollment: 159
Study Start Date: July 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (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

Contacts
Contact: Annetine Gelijns, PhD 212-659-9567 annetine.gelijns@mssm.edu
Contact: Ellen Moquete, BSN 212-659-9651 ellen.moquete@mssm.edu

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Michael Bowdish, MD    323-442-5849    michael.bowdish@med.usc.edu   
Contact: Edward Lozano    323-409-5573    edwardlo@med.usc.edu   
Principal Investigator: Michael Bowdish, MD         
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Joseph Woo, MD    650-725-3828    joswoo@stanford.edu   
Contact: Kokil Bakshi    650-498-1232    kbakshi@stanford.edu   
Principal Investigator: Joseph Woo, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Bartley Griffith, MD    410-328-3822    bgriffith@smail.umaryland.edu   
Contact: Zahid Noor, PhD    410-328-4914    zanoor@som.umaryland.edu   
Principal Investigator: Bartley Griffith, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Francis Pagani, MD, PhD    734-647-2894    fpagani@umich.edu   
Contact: Lydia McGowan, MS, CCRP    734-647-7958    lydiamcg@med.umich.edu   
Principal Investigator: Francis Pagani, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Hassan Nemeh, MD       HNEMEH1@hfhs.org   
Contact: Carly Cavazos    (313) 916-5619    ccavazo1@hfhs.org   
Principal Investigator: Hassan Nemeh, MD         
United States, New York
Montefiore Einstein Heart Center Recruiting
Bronx, New York, United States, 10467
Contact: Daniel Goldstein, MD    718-920-2144    dgoldste@montefiore.org   
Contact: Juan Garcia, RN    718-920-6742    jugarcia@montefiore.org   
Principal Investigator: Daniel Goldstein, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Yoshifumi Naka, MD    212-305-0828    yn33@columbia.edu   
Contact: Lyn Goldsmith, MA, RN, CCRC    212-342-0261    lg2240@columbia.edu   
Principal Investigator: Yoshifuma Naka, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Carmelo Milano, MD    919-684-3243    carmelo.milano@duke.edu   
Contact: Kathleen Lane, BSN, RN, CRCIII    (919) 684-2037    kathleen.lane@duke.edu   
Principal Investigator: Carmelo Milano, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Nader Moazami, MD    216-444-6708    moazamn@ccf.org   
Contact: Michelle Garcia, B.S.N., CCRC    (216) 444-7753    GARCIAM1@ccf.org   
Principal Investigator: Nader Moazami, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Denise Fadorson       Denise.Fadorsen@osumc.edu   
Principal Investigator: Bryan Whitson, Whitson         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Pavan Atluri, MD    215-662-2956    pavan.atluri@uphs.upenn.edu   
Contact: Mary Lou Mayer, BSN, CCRN, CCRC    215-662-7981    Marylou.mayer@uphs.upenn.edu   
Principal Investigator: Pavan A Atluri, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Robert Kormos, MD    412-648-6259    kormosrl@upmc.edu   
Contact: Liz Younkin, RN    412-647-0749    younkineaq@upmc.edu   
Principal Investigator: Robert Kormos, MD         
United States, Texas
Baylor Research Institute Recruiting
Plano, Texas, United States, 75093
Contact: Brian Lima, MD    214-820-7100    Brian.lima@baylorhealth.edu   
Contact: Jasmin Cochran       Jasmine.Cochran@BSWHealth.org   
Principal Investigator: Brian Lima, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Craig Selzman, MD    801-587-9348    Craig.Selzman@hsc.utah.edu   
Contact: Camila Varga    801-587-9185    Camila.vargas@hsc.utah.edu   
Principal Investigator: Craig Selzman, MD         
United States, Virginia
University of Virginia Health Systems Recruiting
Charlottesville, Virginia, United States, 22908
Contact: John Kern, MD    434-982-4301    jak3r@virginia.edu   
Contact: Sandra Burks, RN    434-243-0315    sgb2c@hscmail.mcc.virginia.edu   
Principal Investigator: John Kern, MD         
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53726
Contact: Takushi Kohmoto, MD    608-262-0540      
Contact: Adam Krajewski    (608) 262-9383    krajewski@surgery.wisc.edu   
Principal Investigator: Takushi Kohmoto, MD         
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: John C Mullen, MD, MSc    650-725-3828    jmullen@ualberta.ca   
Contact: Asvina Bissounauth    780-407-6327    asvina.bissonauth@albertahealthservices.ca   
Principal Investigator: John C Mullen, MD, MSc         
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Terrance Yau, MD, MSc    416-340-4074    terry.yau@uhn.ca   
Contact: Katherine Tsang, RN, BScN    416-340-3280    Katherine.Tsang@uhn.ca   
Principal Investigator: Terrence Yau, MD, MSc         
Canada, Quebec
Institut Universitaire de Cardiologie de Quebec (Hopital Laval) Recruiting
Québec City, Quebec, Canada, G1V 4G5
Contact: Eric Charbonneau, MD    418-656-4717    eric.charbonneau@criucpq.ulaval.ca   
Contact: Patricia Landry    418 656-8711 ext 5751    Patricia.Landry@criucpq.ulaval.ca   
Principal Investigator: Eric Charbonneau, MD         
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 ( US NIH Grant/Contract Award Number )
Study First Received: February 9, 2015
Last Updated: February 17, 2017

Keywords provided by 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 March 29, 2017