Status:
COMPLETED
Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
University College, London
Queen Mary University of London
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00765453
Start Date
March 1 2008
End Date
March 1 2018
Last Update
March 2 2020
Active Locations (5)
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1
Rigshopitalet, Unversity of Copenhagen
Copenhagen, Denmark
2
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
3
London Chest Hospital, Barts and The London NHS Trust
Bethnal Green, London, United Kingdom, E2 9JX
4
The Heart Hosptial, UCLH Foundation Trust
London, United Kingdom