Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Summary
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
Description
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Myocardial Infarction
Intervention
Prochymal®, Placebo
Location
Mercy Gilbert Medical Center / Catholic Health Care West
Gilbert
Arizona
United States
85297
Status
Recruiting
Source
Osiris Therapeutics
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00877903
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Anterior Wall Myocardial Infarction
MYOCARDIAL INFARCTION in which the anterior wall of the heart is involved. Anterior wall myocardial infarction is often caused by occlusion of the left anterior descending coronary artery. It can be categorized as anteroseptal or anterolateral wall myocardial infarction.
Inferior Wall Myocardial Infarction
MYOCARDIAL INFARCTION in which the inferior wall of the heart is involved. It is often caused by occlusion of the right coronary artery.
Heart Rupture, Post-infarction
Laceration or tearing of cardiac tissues appearing after MYOCARDIAL INFARCTION.
Myocardial Bridging
A malformation that is characterized by a muscle bridge over a segment of the CORONARY ARTERIES. Systolic contractions of the muscle bridge can lead to narrowing of coronary artery; coronary compression; MYOCARDIAL ISCHEMIA; MYOCARDIAL INFARCTION; and SUDDEN CARDIAC DEATH.
Acute Coronary Syndrome
An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.
Clinical Trials
Efficacy Study of Erythropoietin After Revascularization in Myocardial Infarction (REVIVAL-3)
The purpose of this study is to determine whether erythropoietin is superior to placebo with respect to left ventricular ejection fraction in patients with ST-elevation myocardial infarcti...
Myocardial Infarction Size Reduction With Atorvastatin
The purpose of this study is to determine if oral atorvastatin administered just before percutaneous coronary angioplasty for acute myocardial infarction improves early and late heart func...
Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction
The purpose of this study is to determine the efficacy of intravenous human beta natriuretic peptide (BNP, Nesiritide) as compared to placebo to prevent adverse post acute myocardial infar...
Sevoflurane In Acute Myocardial Infarction
Ischemic postconditioning can reduce myocardial injury following myocardial infarction. A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is t...
The study is an open, single center, observational study at the Cardiology Dept at Uppsala University Hospital. The number of patients included will be 410. The objectives are to: Evaluat...
PubMed Articles
Background-Erythropoietin improves myocardial function in experimental models of myocardial infarction. The aim of the present study was to determine the value of erythropoietin in patients with acute...
Introduction: There are only very few data on gender differences in patients with ST-elevation myocardial infarction. Aim: To compare the clinical data and prognosis of patients with ST-elevation myoc...
Effects of folic acid plus vitamin B12 vs placebo in myocardial infarction survivors.
The purpose of this study was to compare 600- and 300-mg clopidogrel loading doses in patients with ST-segment elevation myocardial infarction (STEMI).
