Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
Condition: Heart Failure; Cardiomyopathy; Ventricular Dysfunction
MeSH terms: Heart Failure; Cardiomyopathies; Ventricular Dysfunction
Intervention: MPC Intramyocardial Injection; Control Solution
Intervention description: Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Failure; Left Ventricular Assist Device; Heart Transplantation; Cardiomyopathy, Destination Therapy; Cell Therapy; Bridge to Transplant

Summary:

      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.
    

Eligibility 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