Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Study hypothesis : The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone. Aims To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography. To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.

Official Title
-----------------
Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Bone marrow derived progenitor cells or placebo infusion
* Other: Placebo infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting to the Heart Attack Centre with acute anterior myocardial infarction (ST elevation in at least 2 contiguous anterior leads ≥ 0.2 mV) and treated with acute PCI with stent implantation within 24 hours after symptom onset Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2). At the time of inclusion patient no longer requires i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump) Significant regional wall motion abnormality in LV angiogram at the time of acute PCI in the LAD territory Age 18 - 80 Years (primary angioplasty confers an adverse prognosis in those over the age of 80 years) Written informed consent in the recruiting centres native language Exclusion Criteria: Regional wall motion abnormality outside the area involved in the index acute myocardial infarction Need to revascularise additional vessels, outside the infarct artery as a planned procedure (these vessels can be treated at baseline) Arteriovenous malformations or aneurysms Active infection, or fever or diarrhoea within last 4 weeks Chronic inflammatory disease Known HIV infection or active hepatitis Neoplastic disease without documented remission within the past 5 years Cerebrovascular insult within 3 months Impaired renal function (creatinine > 200mmol) at the time of cell therapy Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5) Anemia (hemoglobin < 8.5 mg/dl) Platelet count < 100.000/µl Hypersplenism Known allergy or intolerance to clopidogrel, heparin or abciximab History of bleeding disorder Gastrointestinal bleeding within 3 months Major surgical procedure or trauma within 2 months Uncontrolled hypertension Pregnancy Mental retardation leading to inability to obtain informed consent Previously performed stem / progenitor cell therapy Participation in another clinical trial within the last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracoronary<br>Patients will be randomised in a 1:1 ratio to receive intracoronary injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route | Other: Bone marrow derived progenitor cells or placebo infusion<br>* Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique<br>|
| Placebo Comparator: Placebo<br>Placebo infusion | Other: Placebo infusion<br>* Placebo infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal change in left ventricular function (ejection fraction) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size |  | 3 months | 
| Longitudinal change in left ventricular function as measured by LV angiography |  | 6 months | 
| Longitudinal change in left ventricular function assessed by echocardiography. |  | 6 months | 
| Change in left ventricular end systolic volume and change in infarct size. |  | 12 months | 
| Longitudinal change in left ventricular function assessed by echocardiography. |  | 12 months | 
| MACE |  | 12 months | 
| Change in Quality of life |  | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart attack, Anterior Myocardial infarction (MI), adult stem cells, bone marrow progenitor cells, bone marrow stem cells, autologous, left ventricular function, intracoronary injection