Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Other: Bone marrow derived progenitor cells or placebo infusion; Other: Placebo infusion

• Registration Number: NCT00765453
• Lead Sponsor: Barts & The London NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2014-03
• Study Completion: 2018-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracoronary	Bone marrow derived progenitor cells or placebo infusion	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
Placebo	Placebo infusion	Placebo infusion

Primary Outcome Measures

Name	Time	Method
Longitudinal change in left ventricular function (ejection fraction)	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (5)

London Chest Hospital, Barts and The London NHS Trust; 🇬🇧 Bethnal Green, London, United Kingdom

The Heart Hosptial, UCLH Foundation Trust; 🇬🇧 London, United Kingdom

The Royal Free Hospital, Royal Free London Foundation Trust; 🇬🇧 London, United Kingdom

Rigshopitalet, Unversity of Copenhagen; 🇩🇰 Copenhagen, Denmark

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland