Cell Therapy in Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-01

Study Completion Date

2014-07-14

Brief Summary

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The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)

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Detailed Description

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This study protocol describes a randomized double blind clinical trial, which main purpose is to evaluate the effect of the autologous bone marrow mononuclear cell (ABMMC) implant in 300 Brazilian patients with ST elevation acute myocardial infarction (STEMI).

Double blind study design was chosen for this trial, based on several phase I and II safety trials of intracoronary autologous bone marrow stem cells transplantation, already published. The study coordinator committee, supported by the Brazilian Health Ministry, therefore has proposed a phase III trial with the purpose of proving the efficacy of this kind of therapy, for a population with a high risk of developing heart failure and of death by cardiovascular cause.

Thus, in this protocol we propose a prospective, double blind, controlled and randomized trial to evaluate the effect of ABMMC transplantation through intracoronary infusion, on systolic left ventricle (LV) function. The main hypothesis of this trial is that patients submitted to autologous bone marrow stem cell implant, after 6 months follow up, will present a 5% relative increase of the ejection fraction (EF) comparing to control group.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blind Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Control group received injection of saline with 5% autologous serum without the suspension of mononuclear cells.

Study Groups

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Treated Group

Intracoronary injection in the infarcted-related artery of 100 million bone marrow mononuclear cells resuspended in a 10 ml solution of saline with autologous serum.

Group Type EXPERIMENTAL

Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation

Intervention Type PROCEDURE

Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum. About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction. ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.

Control Group

Intracoronary injection in the infarcted-related artery of placebo solution consisting of a saline containing autologous blood serum.

Group Type PLACEBO_COMPARATOR

Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation

Intervention Type PROCEDURE

Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum. About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction. ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.

Interventions

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Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation

Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum. About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction. ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.

Intervention Type PROCEDURE

Other Intervention Names

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Catheter based stem cell delivery

Eligibility Criteria

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Inclusion Criteria

* Patients will be eligible if presenting all characteristics described below:

* ST segment elevation myocardial infarction in two or more contiguous leads, and according to the WHO definition, at least one of the following two:

i) Presence of chest pain. ii) Elevation of the myonecrosis markers.
* Age between 30 and 80 years old.
* Ejection fraction ≤50% on Echocardiogram (Simpson) and segmentary dysfunction of the infarction area, measured between the 3rd and 5th day post AMI.

Among patients submitted to thrombolytic therapy, the angioplasty of the related artery should be preferably done up to 24h after thrombolysis, with a maximum deadline of 72h after thrombolysis.

* Cardiac arrest or Killip IV AMI at admission with need of ventilatory support.
* Cardiogenic shock persisting up to the third day after AMI (with need of Intra-aortic balloon pump or vasopressors).
* AMI mechanical complications (ventricular septal defect, papillary muscle rupture, and left ventricular free wall rupture).
* Significant valve disease, defined as aortic stenosis (mean systolic pressure gradient across the aortic valve \>50mmHg), mitral stenosis with a valvar area less than 1,5 cm,2 moderate to severe aortic and/or mitral regurgitation.
* Chronic use of immunosuppressive agents.
* \> 2,0 mg/dl creatinine or previous dialysis treatment.
* Presence of fever on the past 48h before injection glaring active systemic infection according to ACCP/SCCM (American College of Chest Physicians/Society of Critical Care Medicine) sepsis definition.
* Sustained ventricular tachycardia 48h after AMI.
* Illicit drugs abuse or alcohol abuse (based on DSM IV).
* Any co morbidity, with survival impact in two years.
* Myocarditis
* Active liver disease
* COPD in continuous steroids use.
* Hematological disease, neoplasm, bone disease or hemostatic disturbances.
* Inflammatory disease or chronicle infectious disease.
* Presence of definitive implantation of a cardiac pace maker or cardiac defibrillator.
* Impossibility to reach a cells suspension of 100 million mononuclear cells due to cells paucity in the bone marrow aspirate.

Exclusion Criteria

* Patients will be ineligible if presenting any of the characteristics described below:

* AMI related artery presenting TIMI \< 3 at the moment f cell injection.
* Left Main Coronary Artery Lesion of \>50% or multivessel coronariopathy (\>70% lesion in vessels with \>2,0mm diameter in left anterior descending, circumflex and right coronary territory) indicating the need for CABG or angioplasty with three or more stents implant.
* Coronary anatomy, after thrombolytic reperfusion, presenting no need for angioplasty with stent implant.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No