Safety and Efficacy on Cell-based Therapy in Patients With Recent Large Acute Myocardial Infarction

Phase 2

Withdrawn

• Conditions: Acute Myocardial Infarction; Heart Failure
• Interventions: Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells; Biological: Placebo

• Registration Number: NCT00691834
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-06
• Study Start: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2012-11
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Be at least 18 years of age and no more than 80 years of age.
• Acute ST-segment elevation MI
• Symptoms suggestive of acute MI
• ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
• Time from symptom onset to enrollment < 120 hours
• Left ventricular dysfunction by contrast ventriculography or echocardiography
• EF above 25 % and lower than 40%
• Focal wall motion akinesis or dyskinesis
• Clearly identifiable infarct artery
• Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement

Exclusion Criteria

• Planned treatment with bypass surgery or prior CABG
• Multi-vessel PCI
• Prior myocardial infarction by history or presence of pathologic Q-waves
• Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
• Successful reperfusion < 3 hrs from symptom onset
• Prior MI or significant chronic heart failure
• Pacemaker/defibrillator
• Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat)
• Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance<25 and/or serum Cr >2.5 mg/dl)
• Baseline hematocrit < 30
• Pregnancy, or lactation/parturition within the past 30 days
• Active or planned treatment with chemotherapy
• Anticipated difficulty with 90-day follow-up
• Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive
• Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial
• Previous enrollment in this trial
• Participation in an investigational drug or device study within the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Intracoronary delivery of unfractionated bone marrow mononuclear cells	Intracoronary delivery of unfractionated bone marrow mononuclear cells
2	Placebo	Intracoronary delivery of placebo

Primary Outcome Measures

Name	Time	Method
Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients	baseline and 90 days
Occurence of arrhythmia, heart failure and death	1 year

Secondary Outcome Measures

Name	Time	Method
Improvement in regional left ventricular function	90 days