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

February 1, 2017 updated by: Raj Makkar, Cedars-Sinai Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • REVITALIZE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and feasibility of intracoronary administration of autologous bone marrow-derived mononuclear cells; Improvement of global left ventricular ejection fraction by cardiac MRI and echocardiography after 4 months.
Time Frame: 4 months from procedure
4 months from procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from Major Adverse Cardiac Event (MACE)
Time Frame: 12 months from procedure
12 months from procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Raj Makkar, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

April 1, 2009

First Posted (Estimate)

April 2, 2009

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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