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

Duke University

Status and phase

Withdrawn

Phase 2

Conditions

Heart Failure

Acute Myocardial Infarction

Treatments

Biological: Placebo

Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00691834

Pro00003467

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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