This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Raj Makkar, Cedars-Sinai Medical Center Identifier:
First received: December 26, 2007
Last updated: February 1, 2017
Last verified: February 2017

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.

Condition Intervention Phase
Myocardial Infarction Drug: Intracoronary Transplantation of Bone Marrow Stem Cells Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REVITALIZE: Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by Raj Makkar, Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Freedom from Major Adverse Cardiac Event (MACE) [ Time Frame: 12 months from procedure ]

Enrollment: 27
Study Start Date: July 2005
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00874354

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Principal Investigator: Raj Makkar, MD Cedars-Sinai Medical Center
  More Information

Responsible Party: Raj Makkar, Director, Interventional Cardiology and Cardiac Catheterization Laboratory, Cedars-Sinai Medical Center Identifier: NCT00874354     History of Changes
Other Study ID Numbers: 4441
Study First Received: December 26, 2007
Last Updated: February 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Raj Makkar, Cedars-Sinai Medical Center:
Myocardial Infarction
Heart Attack
Stem Cells
Bone Marrow Derived Mononuclear Cells
Congestive Heart Failure
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on August 18, 2017