Acute Myocardial InfarctionSELECT-AMINCT00529932
A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
A study testing CD133+ infusion in people with Acute Myocardial Infarction, run by Jozef Bartunek at 5 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- CD133+ infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Sep 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
Official title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
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).
- Conditions
- Acute Myocardial Infarction
- Being tested
- CD133+ infusion, placebo infusion
- Keywords
- Acute Myocardial Infarction, Celltherapy, Bone Marrow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD133+ infusionOther
Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).
placebo infusionOther
Buffered normal saline will be infused in the coronary artery during an angiography.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries Receives: Other: CD133+ infusion |
| 2 | Placebo comparator | 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. Receives: Other: placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at 6 and 24 months
Secondary outcomes (4)
SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: prior to the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2011
- Study completionDec 2012
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jozef Bartunek
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor-investigator, Jozef Bartunek, Onze Lieve Vrouw Hospital
- Investigators
- Jozef Bartunek, MD, Study chair, OLVZ AalstJonathan Hill, MD, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529932
- Sponsor's protocol ID
- SELECT-AMI
- Acronym
- SELECT-AMI
- Status last verified
- Apr 2015
- First submitted
- 13 Sep 2007
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00529932
- Acronym / sponsor ID
- SELECT-AMI / SELECT-AMI
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, Celltherapy, Bone Marrow
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Jozef BartunekUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Sep 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: CD133+ infusionEnriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries |
| 2 | Placebo comparator | Other: placebo infusionControl 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD133+ infusionSubjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography). | Other | 1 |
| placebo infusionBuffered normal saline will be infused in the coronary artery during an angiography. | Other | 2 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jozef Bartunek, MD study chair
OLVZ Aalst
Jonathan Hill, MD study chair
King's College London
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD133+ infusion in people with Acute Myocardial Infarction, run by Jozef Bartunek at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, France, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: at 6 months post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.