Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Heart Function in People Receiving an LVAD
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Mesenchymal Precursor cells (RevascorTM); Cryoprotective media alone
Intervention description: Participants will receive intramyocardial injections of low dose (25 million) or higher dose (75 million) MPCs (in sequential cohorts).; Participants will receive intramyocardial injections of cryoprotective media (placebo).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mesenchymal Precursor Cells; Left Ventricular Assist Device; LVAD; Congestive Heart Failure; Stem Cells

Summary:

      Left ventricular assist devices (LVADs) are one treatment option for people with congestive
      heart failure. This study will evaluate the safety of injecting mesenchymal precursor cells
      (MPCs) into the heart during LVAD implantation surgery and examine if injecting MPCs into the
      heart is effective at improving heart function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent, release of medical information, and Health Insurance
             Portability and Accountability Act (HIPAA) documents

          -  Age 18 years or older

          -  If the participant 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 LVAD implantation

          -  Female participants of childbearing potential must have a negative serum pregnancy
             test at screening

          -  Admitted to the clinical center at the time of study entry

          -  Listed with the United Network for Organ Sharing (UNOS) for heart transplantation

          -  Clinical indication and accepted candidate for implantation of an FDA- approved LVAD
             as a bridge to transplantation

        Exclusion Criteria:

          -  Cardiothoracic surgery within 30 days of study entry

          -  Heart attack within 30 days of study entry

          -  Prior heart transplantation, left ventricular (LV) reduction surgery, or
             cardiomyoplasty

          -  Acute reversible cause of heart failure (e.g., myocarditis, profound hypothyroidism)

          -  Anticipated requirement for biventricular mechanical support

          -  Stroke within 30 days of study entry

          -  Received investigational intervention within 30 days of study entry

          -  Platelet count less than 100,000/uL within 24 hours of study entry

          -  Active systemic infection within 48 hours of study entry

          -  Presence of greater than 10% anti-human leukocyte antigen (HLA) antibody titers with
             known specificity to the MPC donor HLA antigens

          -  Known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products

          -  History of cancer prior to screening (excluding basal cell carcinoma)

          -  Acute or chronic infectious disease, including but not limited to human
             immunodeficiency virus (HIV)

          -  Treatment and/or an incompleted follow-up treatment of any investigational therapy
             within 6 months of study entry

          -  Active participation in other research therapy for cardiovascular repair/regeneration

          -  Prior recipient of stem precursor cell therapy for cardiac repair

          -  Pregnant or breastfeeding at the time of study entry