Safety and Efficacy on Cell-Based Therapy in Patients With Recent Large Acute Myocardial Infarction
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 11/30/-0001 |
| Start Date: | August 2009 |
| End Date: | December 2011 |
| Contact: | Christopher B Granger, MD |
| Email: | christopher.granger@duke.edu |
| Phone: | 919-668-8900 |
ReNEW: A Phase 2, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Autologous Bone Marrow Mononuclear Cell Transfer for Myocardial Salvage in Acute Myocardial Infarction
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.
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
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