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

This study has been terminated.
(Insufficient recruitment)
King's College London
Information provided by (Responsible Party):
Jozef Bartunek, Onze Lieve Vrouw Hospital Identifier:
First received: September 13, 2007
Last updated: April 21, 2015
Last verified: April 2015
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: Quadruple (Participant, Care Provider, 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 Jozef Bartunek, 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 ]
  • 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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 19
Study Start Date: September 2007
Study Completion Date: December 2012
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.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00529932

OLVZ Aalst
Aalst, Belgium, 9400
CHU ST-Pierre
Brussels, Belgium
Hôpital Cardiologique
Lille, France
Catharina Ziekenhuis
Eindhoven, Netherlands
United Kingdom
King's College University Hospital
London, United Kingdom
Sponsors and Collaborators
Jozef Bartunek
King's College London
Study Chair: Jozef Bartunek, MD OLVZ Aalst
Study Chair: Jonathan Hill, MD King's College London
  More Information

Responsible Party: Jozef Bartunek, Onze Lieve Vrouw Hospital Identifier: NCT00529932     History of Changes
Other Study ID Numbers: SELECT-AMI
Study First Received: September 13, 2007
Last Updated: April 21, 2015

Keywords provided by Jozef Bartunek, Onze Lieve Vrouw Hospital:
Acute Myocardial Infarction
Bone Marrow

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on August 23, 2017