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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University College, London
Queen Mary University of London
Information provided by (Responsible Party):
Anthony Mathur, Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00765453
First received: October 2, 2008
Last updated: July 10, 2013
Last verified: July 2013

October 2, 2008
July 10, 2013
March 2008
April 2014   (final data collection date for primary outcome measure)
Longitudinal change in left ventricular function (ejection fraction) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Longitudinal change in left ventricular function (ejection fraction) as measured by cardiac MRI. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00765453 on ClinicalTrials.gov Archive Site
  • Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Longitudinal change in left ventricular function as measured by LV angiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Longitudinal change in left ventricular function assessed by echocardiography. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Change in left ventricular end systolic volume and change in infarct size. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Longitudinal change in left ventricular function assessed by echocardiography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Longitudinal change in left ventricular function (ejection fraction) Reduction of left ventricular end systolic volume, Change in regional wall motion in infarct area and Change in infarct mass as measured by cardiac MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in global ejection fraction as measured by LV angiography and improvement of myocardial contractility, assessed by contrast echocardiogram(wall motion score index). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Major adverse cardiac events (MACE), Death (independent of cause and sudden death), myocardial infarction (Q-wave and Non-Q-wave), coronary revascularization [coronary bypass or PCI). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • LV function as measured by cardiac MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction
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 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Other: Bone marrow derived progenitor cells or placebo infusion
    Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique
  • Other: Placebo infusion
    Placebo infusion
  • Experimental: Intracoronary
    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
    Intervention: Other: Bone marrow derived progenitor cells or placebo infusion
  • Placebo Comparator: Placebo
    Placebo infusion
    Intervention: Other: Placebo infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
June 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Switzerland,   United Kingdom
 
NCT00765453
07/Q0603/76, 2007-002-144
Yes
Anthony Mathur, Barts & The London NHS Trust
Barts & The London NHS Trust
  • University College, London
  • Queen Mary University of London
Principal Investigator: Anthony Mathur, FRCP FESC Ph Barts and the London NHS Trust
Barts & The London NHS Trust
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP