Clinical trial NCT00874354: Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction
Official title: REVITALIZE: Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myocardial Infarction
Keywords: Myocardial Infarction
Heart Attack
Infarct
Stem Cells
Bone Marrow Derived Mononuclear Cells
CHF
Congestive Heart Failure
Stent
PCI
Percutaneous Coronary Intervention
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 4 months from procedure
Secondary outcomes:
measure: Freedom from Major Adverse Cardiac Event (MACE)
timeFrame: 12 months from procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Raj Makkar, MD
role: PRINCIPAL_INVESTIGATOR
References: