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
  Purpose

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.

Condition Intervention Phase
Acute Myocardial Infarction
Other: Bone marrow derived progenitor cells or placebo infusion
Other: Placebo infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Longitudinal change in left ventricular function (ejection fraction) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Bone marrow derived progenitor cells or placebo infusion
Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique
Placebo Comparator: Placebo
Placebo infusion
Other: Placebo infusion
Placebo infusion

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765453

Locations
Denmark
Rigshopitalet, Unversity of Copenhagen
Copenhagen, Denmark
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
United Kingdom
London Chest Hospital, Barts and The London NHS Trust
Bethnal Green, London, United Kingdom, E2 9JX
The Heart Hosptial, UCLH Foundation Trust
London, United Kingdom
The Royal Free Hospital, Royal Free London Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Barts & The London NHS Trust
University College, London
Queen Mary University of London
Investigators
Principal Investigator: Anthony Mathur, FRCP FESC Ph Barts and the London NHS Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Anthony Mathur, Professor, Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT00765453     History of Changes
Other Study ID Numbers: 07/Q0603/76, 2007-002-144
Study First Received: October 2, 2008
Last Updated: July 10, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Barts & The London NHS Trust:
Heart attack
Anterior Myocardial infarction (MI)
adult stem cells
bone marrow progenitor cells
bone marrow stem cells
autologous
left ventricular function
intracoronary injection

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Anterior Wall Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014