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

Primary Purpose

Acute Myocardial Infarction

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CD133+ infusion
placebo infusion
Sponsored by
Jozef Bartunek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction, Celltherapy, Bone Marrow

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • OLVZ Aalst
  • CHU ST-Pierre
  • Hôpital Cardiologique
  • Catharina Ziekenhuis
  • King's College University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries

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.

Outcomes

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.
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.

Secondary Outcome Measures

SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure.
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.
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.
SECONDARY EFFICACY ENDPOINTS (c) The feasibility of the CliniMACS® Reagent System to yield 5x106 CD133+ cells from 100-150 ml of autologous bone marrow.

Full Information

First Posted
September 13, 2007
Last Updated
April 21, 2015
Sponsor
Jozef Bartunek
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT00529932
Brief Title
A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
Acronym
SELECT-AMI
Official Title
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jozef Bartunek
Collaborators
King's College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute Myocardial Infarction, Celltherapy, Bone Marrow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CD133+ infusion
Intervention Description
Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).
Intervention Type
Other
Intervention Name(s)
placebo infusion
Intervention Description
Buffered normal saline will be infused in the coronary artery during an angiography.
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jozef Bartunek, MD
Organizational Affiliation
OLVZ Aalst
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jonathan Hill, MD
Organizational Affiliation
King's College London
Official's Role
Study Chair
Facility Information:
Facility Name
OLVZ Aalst
City
Aalst
ZIP/Postal Code
9400
Country
Belgium
Facility Name
CHU ST-Pierre
City
Brussels
Country
Belgium
Facility Name
Hôpital Cardiologique
City
Lille
Country
France
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
King's College University Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

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A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

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