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

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ClinicalTrials.gov Identifier: NCT00765453
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : March 2, 2020
Sponsor:
Collaborators:
University College, London
Queen Mary University of London
Information provided by (Responsible Party):
Anthony Mathur, Barts & The London NHS Trust

Tracking Information
First Submitted Date  ICMJE October 2, 2008
First Posted Date  ICMJE October 3, 2008
Last Update Posted Date March 2, 2020
Study Start Date  ICMJE March 2008
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
Longitudinal change in left ventricular function (ejection fraction) [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
Longitudinal change in left ventricular function (ejection fraction) as measured by cardiac MRI. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
  • 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 ]
  • MACE [ Time Frame: 12 months ]
  • Change in Quality of life [ Time Frame: 6 and 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
  • 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 ]
  • 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 ]
  • 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 ]
  • Quality of life [ Time Frame: 6 months ]
  • LV function as measured by cardiac MRI [ Time Frame: 12 months ]
  • MACE [ Time Frame: 12 months ]
  • Quality of life [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction
Official Title  ICMJE Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2013)
100
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2008)
102
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765453
Other Study ID Numbers  ICMJE 07/Q0603/76
2007-002-144
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony Mathur, Barts & The London NHS Trust
Study Sponsor  ICMJE Barts & The London NHS Trust
Collaborators  ICMJE
  • University College, London
  • Queen Mary University of London
Investigators  ICMJE
Principal Investigator: Anthony Mathur, FRCP FESC Ph Barts and the London NHS Trust
PRS Account Barts & The London NHS Trust
Verification Date February 2020

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