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

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