Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)

The standard of care treatment for acute myocardial infarction (AMI) usually includes
immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants,
Beta-Blockers, nitrates and Ace-inhibitors. However, because salvaging the viable myocardium
is dependent on early reperfusion, only a minority of patients will reach the hospital within
the time-window for myocardial rescue. Thus, even if the patient manages their tobacco use,
hypertension, lipid levels, diabetes, weight and exercise, many patients will go on to
develop Congestive Heart Failure (CHF). Though the medical management for CHF may improve
symptoms and slow disease progression, such treatment cannot restore a functioning
myocardium. A therapy that could improve the myocardial remodeling process and reduce the
incidence or severity of CHF following acute MI would provide a significant benefit. The
characteristics and biologic activity of Prochymal®, along with a good safety profile in
human trials to date, suggest that Prochymal® may be a good candidate for addressing this
unmet medical need.

Inclusion Criteria:

- Male or female between 21 and 85 years old, inclusive

- First heart attack within 7 days prior to randomization and drug infusion

- Baseline LVEF 20-45%

- Hemodynamically stable within 24 hours prior to randomization

- Adequate pulmonary function

Exclusion Criteria:

- Previous medical history of heart attack, heart failure, significant valvular heart
disease, aortic dissection

- Pacemaker or other device

- Pregnant, breast-feeding, or intends to become pregnant during the study

- Allergy to cow or pig derived products

- Evidence of active malignancy or prior history of active malignancy

- Major surgical procedure or major trauma within the past 14 days

- Autoimmune disease (e.g., Lupus, Multiple Sclerosis)

- Any medical condition, which in the opinion of the Investigator, renders participation
unsuitable

- Undergone pharmacologic cardioversion or external defibrillation within 24 hours of
randomization.

- Experienced cardiac arrest more than 36 hours after presentation to site or within 24
hours of randomization.