This trial is active, not recruiting.

Condition acute myocardial infarction
Treatments bone marrow derived progenitor cells or placebo infusion, placebo infusion
Phase phase 2
Sponsor Barts & The London NHS Trust
Collaborator University College, London
Start date March 2008
End date March 2014
Trial size 100 participants
Trial identifier NCT00765453, 07/Q0603/76, 2007-002-144


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.


- 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
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
bone marrow derived progenitor cells or placebo infusion
Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique
(Placebo Comparator)
Placebo infusion
placebo infusion
Placebo infusion

Primary Outcomes

Longitudinal change in left ventricular function (ejection fraction)
time frame: 1 year

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Anthony Mathur, FRCP FESC Ph
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Barts & The London NHS Trust.