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

• Status: Completed
• Trial end date: 2016-03-14
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mesoblast International Sàrl; Mesoblast, Inc.
• Treatments: Remestemcel-l

Criteria

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 left ventricular ejection fraction (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.