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Completed

NCT Number: NCT00765453

Bone Marrow Derived Adult Stem Cells for 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.

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Key information

Conditions

Acute Myocardial Infarction Anterior Wall Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshopitalet, Unversity of Copenhagen, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone marrow derived progenitor cells or placebo infusion

Other

Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique

placebo infusion

Other

Placebo infusion

Primary outcomes

  1. Longitudinal change in left ventricular function (ejection fraction)

    Time frame: 1 year

Secondary outcomes

  1. Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size

    Time frame: 3 months

  2. Longitudinal change in left ventricular function as measured by LV angiography

    Time frame: 6 months

  3. Longitudinal change in left ventricular function assessed by echocardiography.

    Time frame: 6 months

  4. Change in left ventricular end systolic volume and change in infarct size.

    Time frame: 12 months

  5. Longitudinal change in left ventricular function assessed by echocardiography.

    Time frame: 12 months

  6. MACE

    Time frame: 12 months

  7. Change in Quality of life

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • Queen Mary University of London
  • University College, London

Registry information

Official study 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

Acronym: REGEN-AMI

Important dates

Study start
2008
Primary completion
2014
Study completion
2018
First posted
Oct 3, 2008
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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