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



Status:Active, not recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:July 2015
End Date:August 2019

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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.

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.

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
We found this trial at
17
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Michael Bowdish, MD
Phone: 323-442-5849
University of Southern California The University of Southern California is one of the world’s leading...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Carmelo Milano, MD
Phone: 919-684-3243
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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750 Highland Avenue
Madison, Wisconsin 53792
Principal Investigator: Tukushi Kohmoto, MD
Phone: 608-262-0540
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Robert Kormos, MD
Phone: 412-648-6259
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Craig Selzman, MD
Phone: 801-587-9348
University of Utah Research is a major component in the life of the U benefiting...
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Principal Investigator: Joseph Woo, MD
Phone: 650-725-3828
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Francis Pagani, MD
Phone: 734-647-2894
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Bartley Griffith, MD
Phone: 410-328-3822
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Bronx, New York 10467
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Charlottesville, Virginia 22908
Principal Investigator: John Kern, MD
Phone: 434-982-4301
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Nader Moazami, MD
Phone: 216-444-6708
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Bryan Whitson, Whitson
Phone: 614-688-7904
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Hassan Nemeh, MD
Phone: 313-916-2688
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Edmonton, Alberta
Principal Investigator: John C Mullen, MD, MSc
Phone: 650-725-3828
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Yoshifuma Naka, MD
Phone: 212-305-0828
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Pavan A Atluri, MD
Phone: 215-662-2956
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Plano, Texas 75093
Principal Investigator: Brian Lima, MD
Phone: 214-820-7100
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