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Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI) - NCT00877903-02111(Clinical Trial 364564)



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City:  Boston
State:  
MA
Zip Code: 02111
Conditions: Myocardial Infarction
Purpose: The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
Study summary: 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.
Criteria: Inclusion Criteria: - Male or female between 21 and 85 years old - First heart attack within 7 days - Baseline LVEF 20-45% Exclusion Criteria: - Previous heart attack - 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
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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