Clinical trial NCT00529932: A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
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
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Celltherapy
Bone Marrow
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2007-09-14
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: 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.
timeFrame: at 6 months post-infusion
measure: 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.
timeFrame: at 6 and 24 months
Secondary outcomes:
measure: SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure.
timeFrame: At all follow up's
measure: 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.
timeFrame: at all follow up's
measure: 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.
timeFrame: at 6 months follow up
measure: SECONDARY EFFICACY ENDPOINTS (c) The feasibility of the CliniMACS® Reagent System to yield 5x106 CD133+ cells from 100-150 ml of autologous bone marrow.
timeFrame: prior to the infusion
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLVZ Aalst
city: Brussels
country: Belgium
facility: CHU ST-Pierre
city: Lille
country: France
facility: Hôpital Cardiologique
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: London
country: United Kingdom
facility: King's College University Hospital
Study officials:
affiliation: OLVZ Aalst
name: Jozef Bartunek, MD
role: STUDY_CHAIR
affiliation: King's College London
name: Jonathan Hill, MD
role: STUDY_CHAIR
References: