An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)

The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to
placebo (vehicle control) on the average per patient number of all-cause deaths,
cardiovascular hospital admissions, and unplanned outpatient or emergency department visits
to treat acute decompensated heart failure, over the 12 months following administration of
investigational product (IP).

Inclusion Criteria:

1. Males and non-pregnant, non-lactating females;

2. Age 30 to 86 years of age;

3. Diagnosis of ischemic dilated cardiomyopathy;

4. LVEF ≤ 35% by echocardiogram;

5. Symptomatic heart failure in NYHA functional class III or IV;

6. Subject is not a candidate for reasonable revascularization procedures that will
produce clinical improvement;

7. Subject is receiving appropriate clinical standard of care heart failure therapy, as
tolerated and as dictated by a subject's current medical condition, for at least 30
days prior to screening;

8. Must have an automatic implantable cardioverter defibrillator (AICD);

9. Worsening heart failure hospitalization or equivalent within 6 months prior to
screening, hospitalization equivalent defined as an unplanned outpatient/emergency
department visit for treatment of acute decompensated heart failure; or have an
N-terminal prohormone B-type natriuretic peptide (NT-proBNP) ≥2000 pg/mL or BNP ≥400
pg/mL within 30 days of screening (including screening); or have a 6-minute walk test
(6MWT) distance of ≤400 meters at screening;

10. Life expectancy of at least 12 months in the opinion of the Investigator;

11. LV wall thickness ≥ 7mm (by echocardiogram) at anticipated target injection area;

12. Hemodynamic stability without IV vasopressors or support devices;

13. Given medical history and concurrent medication, subject is an acceptable candidate
for bone marrow aspiration and cardiac catheterization and transendocardial injection
procedures in the opinion of the Investigator;

14. Willing and able to comply scheduled visits and tolerate study procedures.

15. Voluntarily provide a personally-signed and dated informed consent.

Exclusion Criteria:

Disease-specific:

1. Severe primary valvular heart disease including, but not limited to, aortic valve
stenosis and insufficiency;

2. VAD implantation, heart transplantation, cardiomyoplasty, left ventricular reduction
surgery, or cardiac shunt implantation;

3. Planned heart failure-related device interventions (e.g., VAD implantation, initial
cardiac resynchronization therapy) or planned cardiac procedures (e.g., heart
transplant, cardiomyoplasty, valvular repair);

4. Current arrhythmias that would prohibit accurate NOGA® electromechanical mapping and
NOGA®-guided injections;

5. LV thrombus (as documented on echocardiography or LV angiography);

6. Myocardial infarction, stroke or transient ischemic attack within 3 months prior to
screening;

7. Percutaneous coronary intervention, valvuloplasty, cardiac surgery, and other major
cardiac procedure within 30 days prior to screening;

8. In the opinion of the Investigator, the subject's left ventricular wall is unsuitable
for transendocardial injections (due to thickness or other reasons).

Medical History:

9. Stroke or transient ischemic attack (TIA) within 3 months of screening;

10. Hemoglobin A1c (HbA1c) ≥ 9% at screening;

11. Diabetic subjects with uncontrolled or untreated proliferative retinopathy as
determined by dilated eye exam administered by a qualified eye care professional as
per American Diabetes Association guidelines;

12. Blood clotting disorder not caused by medication (e.g., thrombophilia);

13. Active malignancy (non-basal cell) requiring surgery, chemotherapy, and/or radiation
in the past 12 months;

14. Drug or alcohol abuse that would interfere with the subject's compliance with study
procedures;

15. Allergies to any equine, porcine, or bovine products;

16. Body mass index (BMI) ≥ 40 kg/m2 at screening;

17. Established chronic kidney disease (CKD) requiring dialysis (Stage 5); estimated
creatinine clearance < 15 mL/min at screening;

18. Subject has allergy or is unable to tolerate cardiac imaging contrast agents; also the
inability to get a good quality echocardiogram image at screening (as determined by
the imaging core lab).

Laboratory Parameters:

19. Abnormal laboratory values (performed at central lab) at screening:

- Platelets < 50,000 μL;

- Hemoglobin < 9.0 g/dL;

- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 3 times the upper
limit of normal (ULN);

- Human immunodeficiency virus 1 (HIV 1), HIV 2, or syphilis positive (rapid plasma
reagin [RPR]);

- Active hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies;

- NOTE: Additional lab tests may be performed per local requirements including but
not limited to: hepatitis B core antibody, human T lymphotropic virus I/II.

Exclusionary Procedures, Devices, or Medication:

20. Subjects receiving anti-angiogenic drugs (e.g., anti-vascular endothelial growth
factor [VEGF]);

21. Chronic exposure to cytotoxic therapy for oncologic or chronic non-oncologic reasons
in the prior 3 months or expected requirement over the course of the study;

22. Concurrent participation in another interventional clinical trial or receiving
experimental intervention within 30 days of screening or having previously been
exposed to Aastrom's ixmyelocel T product or previously received allogeneic cell
therapy, autologous cell therapy cultured with animal proteins.

23. In the opinion of the Investigator, the subject is unsuitable for cellular therapy or
has a food/drug allergy, surgical or medical condition, clinically significant
psychiatric disorders, poor nutritional status, or lab abnormality requiring further
medical evaluation that may interfere with the investigational product, interfere with
the study results' interpretation, interfere with the subject's ability to complete
the study or compromise the subject's safety.