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A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction (SELECT-AMI)

This study is currently recruiting participants.
Verified May 2011 by Onze Lieve Vrouw Hospital
Sponsor:
Collaborator:
King's College London
Information provided by:
Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier:
NCT00529932
First received: September 13, 2007
Last updated: May 24, 2011
Last verified: May 2011
History of Changes
  Purpose

An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial with central core lab analyses to determine the safety of intra-coronary infusion of enriched CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial infarction (STEMI).


Condition Intervention
Acute Myocardial Infarction
 Other: CD133+ infusion
Other: placebo infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Onze Lieve Vrouw Hospital:

Primary Outcome Measures:
  • PRIMARY SAFETY ENDPOINT Comparison of progression in coronary atherosclerosis burden proximal and distal to the stented segment of the infarct-related artery in treated and control groups. [ Time Frame: at 6 months post-infusion ] [ Designated as safety issue: No ]
  • PRIMARY EFFICACY ENDPOINT Comparison of changes in myocardial thickening in non-viable akinetic / hypokinetic LV wall segments as determined by cardiac magnetic resonance imaging (cMRI) in treated and control groups. [ Time Frame: at 6 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure. [ Time Frame: At all follow up's ] [ Designated as safety issue: Yes ]
  • SECONDARY EFFICACY ENDPOINTS (a) Changes in % global LV ejection fraction (EF) compared with baseline as determined by cMRI and echocardiography pre- and post-cell infusion subsequent to primary PCI. [ Time Frame: at all follow up's ] [ Designated as safety issue: No ]
  • SECONDARY EFFICACY ENDPOINTS (b)Assessment of epicardial resistance and microvascular resistance, index of myocardial resistance and absolute coronary blood flow measurements in the infarct related artery. [ Time Frame: at 6 months follow up ] [ Designated as safety issue: No ]
  • SECONDARY EFFICACY ENDPOINTS (c) The feasibility of the CliniMACS® Reagent System to yield 5x106 CD133+ cells from 100-150 ml of autologous bone marrow. [ Time Frame: prior to the infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries
 Other: CD133+ infusion
Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).
Placebo Comparator: 2
Control group patients will receive 3 injections of 0.3 mL each of buffered normal saline (the vehicle used for cell suspension) into comparable vessels. Subjects will have an identical intra-coronary injection procedure to those randomized to autologous CD133+ progenitor cell injections.
 Other: placebo infusion
Buffered normal saline will be infused in the coronary artery during an angiography.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary PCI for acute STEMI between 2-24 hours after onset of chest pain.
  • ST-segment elevation >=2mm in >=3 adjacent leads.
  • Presence of severe hypokinesia and/or akinesia in >=2 adjacent segments on echocardiogram at 48-72 hrs after primary PCI.
  • Age between 20 and 75 years.

Exclusion Criteria:

  • Pregnant or lactating.
  • Prior history of myocardial infarction before index event.
  • Decompensated congestive heart failure.
  • Pre-existent LV dysfunction (EF <45% prior to admission)
  • Cardiomyopathy.
  • Previous cardiac surgery.
  • Congenital heart disorder.
  • Serum creatinine >200 Mmol/L.
  • Presence of permanent pacemaker or implantable defibrillator.
  • Contraindication to bone marrow aspiration.
  • History of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma and/or cervical carcinoma.
  • Sustained or inducible VT >48 hours post primary PCI.
  • Three vessel coronary artery disease necessitating intervention within 4 months.
  • Immune compromise including chronic human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
  • Presence of chronic systemic inflammatory disorders.
  • Previous autologous or allogeneic bone marrow or peripheral stem cell transplant or prior solid organ transplantation.
  • Low hemoglobin, white blood cell, absolute neutrophil and/or platelet count.
  • Any condition associated with a life expectancy of less than 6 months.
  • Participation in unrelated research involving investigational pharmacological agent(s) 30 days before planned dosing.
  • Current alcohol or drug abuse.
  • Inability to provide written informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529932

Contacts
Contact: Jozef Bartunek, MD jozef.bartunek@olvz-aalst.be
Contact: Jonathan Hill, MD jonathan.hill@kcl.ac.uk

Locations
Belgium
OLVZ Aalst Recruiting
Aalst, Belgium, 9400
Principal Investigator: Marc Vanderheyden, MD            
Principal Investigator: Jozef Bartunek, MD            
CHU ST-Pierre Recruiting
Brussels, Belgium
Principal Investigator: Jean L Vandenbossche, MD            
France
Hôpital Cardiologique Not yet recruiting
Lille, France
Principal Investigator: Eric Van Belle, MD            
Principal Investigator: Frederic Mouquet, MD            
Netherlands
Catharina Ziekenhuis Not yet recruiting
Eindhoven, Netherlands
Principal Investigator: Nico Pijls, MD            
United Kingdom
King's College University Hospital Not yet recruiting
London, United Kingdom
Principal Investigator: Jonathan Hill, MD            
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
King's College London
Investigators
Study Chair: Jozef Bartunek, MD OLVZ Aalst
Study Chair: Jonathan Hill, MD King's College London
  More Information

No publications provided

Responsible Party: Jozef Bartunek, MD, Cardiovascular center Aalst
ClinicalTrials.gov Identifier: NCT00529932     History of Changes
Other Study ID Numbers: SELECT-AMI
Study First Received: September 13, 2007
Last Updated: May 24, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Onze Lieve Vrouw Hospital:
Acute Myocardial Infarction
Celltherapy
Bone Marrow

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

ClinicalTrials.gov processed this record on June 17, 2013