A Phase IIa, Single-blind, Placebo-controlled, Crossover, Multi-center, Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-ischemic Etiology

The study will enroll 20 subjects and will consist of 2 cohorts. Enrolled subjects will be
randomized at 1:1 into an experimental group (n=10) or a placebo group (n=10), respectively.
Subjects in the experimental group will receive 1.5 million cells per kg and subjects in the
placebo group will receive 1 mL/kg Lactated Ringer's Solution. At 90 days the two groups
will change arms and the placebo group will receive 1.5 million cells per kg and the
initially treated group will receive a Lactated Ringer's Solution (LRS) at a volume of 1
mL/kg.

Inclusion Criteria:

1. Males and females ≥18 years of age

2. LVEF ≤35% on echocardiogram within 6 months of randomization to undergo MRI

3. Screening cardiac MRI at baseline with

1. Ejection fraction ≤40%

2. No evidence of hyper-enhancement

4. Patients with non-ischemic heart failure etiology, as documented by absent or
non-obstructive coronary artery disease on x-ray angiography or coronary computed
tomography within the past 3 years

5. On stable maximally tolerated medical therapy (at the discretion of the
investigator) including ACE-inhibitors, angiotensin receptor blockers, beta-blockers,
and mineralocorticoid receptor antagonists, as tolerated, for at least 6 months

6. NYHA class II-III symptoms

7. Ability to understand and provide signed informed consent

8. Reasonable expectation that patient will receive standard post-treatment care and
attend all scheduled safety follow-up visits

Exclusion Criteria:

- 1. Pregnant or nursing women or those of childbearing age and not using an effective
method of contraception.

2. Acute myocardial infarction, acute coronary syndrome, or stroke within 3 months 3.
Cardiac surgery within 3 months prior to randomization or the likelihood of a
requirement for such procedures during the study period 4. Current ICD or CRT or
implantation planned with 6 months of infusion 5. Presence of clinically significant,
uncorrected valvular heart disease, hypertrophic or restrictive cardiomyopathy,
active myocarditis, or uncontrolled hypertension 6. History of cardiac arrest or
life-threatening arrhythmias within 3 months 7. Treatment with parenteral inotropic
agents within 1 month of randomization 8. Anticipated cardiac transplantation within
1 year 9. Illness other than heart failure with life expectancy less than 1 year 10.
Received an experimental drug or device within 30 days of randomization 11. Left
ventricular assist device or implantation planned in the next 6 months 12. Patients
with complex congenital heart disease 13. Uncontrolled seizure disorder. 14. Presence
of immune deficiency. 15. Clinically significant hematologic, hepatic, or renal
impairment as determined by screening clinical laboratory tests.

16. Presence of any other clinically-significant medical condition, psychiatric
condition, or laboratory abnormality, that in the judgment of the investigator or
sponsor for which participation in the study would pose a safety risk to the subject
17. Inability to comply with the conditions of the protocol. 18. Malignancy within
the previous five years, except adequately treated basal cell carcinoma, provided
that it is neither infiltrating nor sclerosing, and carcinoma in situ of the cervix.

19. Active myocarditis or early postpartum cardiomyopathy (within six months). 20.
Systemic corticosteroids, cytostatics, immunosuppressive drug therapy
(cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting
or cytotoxic drugs taken within four weeks prior to study treatment.

21. Porphyria. 22. Allergy to sodium citrate or any "caine" type of local anesthetic.
23. Any contraindication for gadolinium use for MRI 24. Patient scheduled for hospice
care. 25. Clinically relevant abnormal findings in the clinical history, physical
examination, ECG, or laboratory tests at the screening assessment that would
interfere with the objectives of the study or would preclude safe completion of the
study. Abnormal findings could include: known HIV infection or other immunodeficiency
state, chronic active viral infection (such as hepatitis B or C), acute systemic
infections (defined as patients undergoing treatment with antibiotics),
gastrointestinal tract bleeding, or any severe or acute concomitant illness or
injury.

26. Any other medical, social, or geographical factor that would make it unlikely
that the patient could comply with study procedures (e.g., alcohol abuse, lack of
permanent residence, severe depression, disorientation, distant location, or
noncompliance)