Status:
COMPLETED
Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This research is being done because currently there is no effective way in regenerating or replacing the heart muscle that has been damaged after a heart attack. The purpose of this study is to test ...
Detailed Description
The main objective of this study is to investigate the safety and clinical outcome of intracoronary infusion of autologous bone marrow cells in patients with myocardial infarction (MI). We hypothesize...
Eligibility Criteria
Inclusion
- Patients with acute myocardial infarction (ST elevation in at least 2 leads ≥ 0.2 mV in V1,V2 or V3 or ≥ 0.1 mV in other leads), treated by one of the following procedures:
- Acute PCI with stent implantation for acute ST elevation MI for either denovo lesions or in-stent thrombosis
- Treatment with thrombolysis followed by PCI with stent implantation.
- Acute PCI / stent implantation has been successful (residual stenosis visually \< 30% and TIMI flow ≥ 2).
- At the time of inclusion (≥ 1 day post PCI) patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- Significant regional wall motion abnormality on echocardiography at the time of acute PCI (ejection fraction ≤ 50% on visual estimation).
- Maximal cardiac troponin elevation ≥ 4 (measured at 37° C)
- Age 18 - 80 Years
- Written informed consent
Exclusion
- Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
- Need to acutely revascularize additional vessels, outside the infarct artery.
- Arteriovenous malformations or aneurysms
- Active infection or fever or diarrhea within last 4 weeks.
- Chronic inflammatory disease
- HIV infection or active hepatitis
- Neoplastic disease without documented remission within the past 5 years.
- Cerebrovascular insult within 3 months
- Impaired renal function (creatinine \> 2 mg/dl) at the time of cell therapy
- Significant liver disease (GOT \> 2x upper limit) or spontaneous INR \> 1.5)
- Anemia (hemoglobin \< 8.5 g/dl)
- Platelet count \< 100,000/µl
- Hypersplenism
- History of bleeding disorder
- Gastrointestinal bleeding within 3 months
- Major surgical procedure or trauma within 2 months
- Uncontrolled hypertension
- Pregnancy
- Mental retardation
- Previously performed stem / mononuclear cell therapy
- Participation in another clinical trial within the last 30 days
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00874354
Start Date
July 1 2005
End Date
June 1 2013
Last Update
February 2 2017
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048