Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction (REGEN-AMI)

Barts & The London NHS Trust

Status: Completed

Conditions: Acute Myocardial Infarction

Treatments: Other: Bone marrow derived progenitor cells or placebo infusion; Other: Placebo infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00765453

07/Q0603/76

2007-002-144

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Intracoronary

Experimental group

Description:

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

Treatment:

Other: Bone marrow derived progenitor cells or placebo infusion

Placebo

Placebo Comparator group

Description:

Placebo infusion

Treatment:

Other: Placebo infusion