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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Onze Lieve Vrouw Hospital.
Recruitment status was  Recruiting
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
  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:


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
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: 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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014