Clinical trial NCT00765453: Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Heart attack
Anterior Myocardial infarction (MI)
adult stem cells
bone marrow progenitor cells
bone marrow stem cells
autologous
left ventricular function
intracoronary injection
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: University College, London
name: Queen Mary University of London
First posted: 2008-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Longitudinal change in left ventricular function (ejection fraction)
timeFrame: 1 year
Secondary outcomes:
measure: Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size
timeFrame: 3 months
measure: Longitudinal change in left ventricular function as measured by LV angiography
timeFrame: 6 months
measure: Longitudinal change in left ventricular function assessed by echocardiography.
timeFrame: 6 months
measure: Change in left ventricular end systolic volume and change in infarct size.
timeFrame: 12 months
measure: Longitudinal change in left ventricular function assessed by echocardiography.
timeFrame: 12 months
measure: MACE
timeFrame: 12 months
measure: Change in Quality of life
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshopitalet, Unversity of Copenhagen
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Bethnal Green
country: United Kingdom
facility: London Chest Hospital, Barts and The London NHS Trust
state: London
city: London
country: United Kingdom
facility: The Heart Hosptial, UCLH Foundation Trust
city: London
country: United Kingdom
facility: The Royal Free Hospital, Royal Free London Foundation Trust
Study officials:
affiliation: Barts and the London NHS Trust
name: Anthony Mathur, FRCP FESC Ph
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choudry F, Hamshere S, Saunders N, Veerapen J, Bavnbek K, Knight C, Pellerin D, Locca D, Westwood M, Rakhit R, Crake T, Kastrup J, Parmar M, Agrawal S, Jones D, Martin J, Mathur A. A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trialdagger. Eur Heart J. 2016 Jan 14;37(3):256-63. doi: 10.1093/eurheartj/ehv493. Epub 2015 Sep 23.
citation: Hamshere S, Choudhury T, Jones DA, Locca D, Mills P, Rothman M, Knight C, Parmar M, Agrawal S, Martin J, Mathur A. A randomised double-blind control study of early intracoronary autologous bone marrow cell infusion in acute myocardial infarction (REGENERATE-AMI). BMJ Open. 2014 Feb 18;4(2):e004258. doi: 10.1136/bmjopen-2013-004258.