Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction

NCT ID: NCT00874354

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2013-06-30

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 whether injecting cells obtained from the patient's bone marrow into the coronary artery can regenerate and replace heart tissue to strengthen heart and prevent heart from dilating and developing heart failure.

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 that patients treated with stem cell therapy will have beneficial effects on left ventricular (LV) remodeling and functional regeneration after MI and successful primary percutaneous coronary intervention (PCI) in setting of prospective randomized controlled trial.

Congestive heart failure (CHF), which is most commonly caused by acute myocardial infarction (AMI), is the most frequent cause of hospitalization in the United States in patients over the age of 65. Although current pharmacotherapy can inhibit neurohormonal activation, this falls short in preventing LV remodeling and the development of CHF. Stem cells are undifferentiated pluripotent cells that can be obtained from the patient and have the potential to proliferate and differentiation into cardiomyocytes. The majority of the data on stem cell transplantation comes from preclinical animal studies. Although the results are interesting and perhaps safe, early phase I clinical studies are small and are very preliminary. Data from large, randomized controlled trials are needed to clarify the short and long term effects of cellular cardiomyoplasty.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous bone marrow stem cells

Patients within 3 to 14 days from percutaneous coronary intervention (PCI) and stent implantation for Acute Myocardial Infarction (AMI) will receive either 50 cc's or 100 cc's of autologous bone marrow mononuclear cells through an intracoronary tranplantation of stem cells into the infarct-related coronary artery.

Group Type: EXPERIMENTAL

Intracoronary Transplantation of Bone Marrow Stem Cells

Intervention Type: DRUG

Intracoronary application of autologous bone marrow-derived mononuclear cells in infarct artery 3 - 14 days after PCI for acute myocardial infarction.

Interventions

Intracoronary Transplantation of Bone Marrow Stem Cells

Intracoronary application of autologous bone marrow-derived mononuclear cells in infarct artery 3 - 14 days after PCI for acute myocardial infarction.

Intervention Type: DRUG

Other Intervention Names

REVITALIZE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Raj Makkar

Director, Interventional Cardiology and Cardiac Catheterization Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raj Makkar, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

4441

Identifier Type: -

Identifier Source: org_study_id