Reperfused Acute Myocardial InfarctionPhase 2TECAM2NCT00984178
Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction
A Phase 2 study testing Granulocite Colony Stimulating Factor treatment (G-CSF) and Bone marrow mononuclear cells in people with Reperfused Acute Myocardial Infarction, run by TECAM Group at 1 site in Spain.
Trial summary
The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Reperfused Acute Myocardial Infarction
- What is being tested?
- Granulocite Colony Stimulating Factor treatment (G-CSF) and Bone marrow mononuclear cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2005to Nov 2009
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Acute myocardial infarction with the following characteristics:
- Clinical symptoms of chest pain lasting >30 minutes, unresponsive to nitroglycerin.
- Typical myocardial enzymatical necrotic curve
- Total summed ST-segment elevation ≥ 6 mm in 12-lead electrocardiogram.
- Akynesis or hypokinesis in infarct-related artery area without contractility abnormalities in the rest of areas.
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- Pharmacological, mechanical or both type reperfusions (facilitated angioplasty) with evidence of normal infarcted area epicardial flow (TIMI grade 3) in the first 24 hours after the beginning of the symptoms
- Successful repair of the infarct-related artery (residual post-stenting stenosis < 30% by visual estimation with epicardial normal flow [grade 3] in the first 24 hours after the beginning of the symptoms or lack of significant residual lesions evidence (<50% visual estimation) in infarct-related artery.
- Lack of evidence of significant lesions in the remaining coronary vessels or adequate revascularization achieved in the first 24 hours after symptoms began.
Who cannot join
- The presence of cardiogenic shock defined as sustained systolic blood pressure less than 90 mm Hg, with no response to fluids or systolic blood pressure less than 100 mm Hg with vasopressors (in absence of bradycardia)
- Suspicion or evidence of infarct mechanical complication
- History of sustained ventricular tachycardia or atrial fibrillation
- Patient with cardiac defibrillator or candidate for its potential implantation.
- Investigational drug treatment in the previous 4 weeks
- Actual or potential use of anti-neoplastic drugs
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- Oncology antecedents in the last 5 years
- Previous treatment with trans myocardial laser revascularization
- Women of childbearing potential
- Severe concomitant disease modifying patient's survival during the study
- Inability to suspend thrombolytic treatment
- Active bleeding or major surgery within 2 weeks forbidding the use of heparin, abciximab or antiplatelet therapy.
- Previous malignant haematology disease (leukaemia or lymphomas) or hypercoagulability disorders (antiphospholipid syndrome, antithrombin, C-protein and S-protein or V Leiden Factor deficiency)
- Previous known renal failure (creatinine > 2.5 mg /dl)
- Any kind of stroke in the last year or whenever episode of haemorrhagic stroke.
- Major surgery pending in the next year
- Previously known vascular disease that prevents from catheterization.
- Evidence of hypersensitivity to Filgrastim, proteins derived from E. coli or any formulation component.
- Inability to give written informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Valladolid
Valladolid, Valladolid, 47002
Alberto San Roman, MD, PhD, 34-665399285, asanroman@secardiologia.es
Alberto San Roman, MD, PhD
About this study
Official title: Randomized Trial Comparing Intracoronary Delivery of Bone Marrow-derived Stem Cells Versus Stem Cell Mobilisation With GCSF, a Combination of Both Therapies and Conventional Treatment in Patients With Reperfused Acute Myocardial Infarction
The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF).
Read the detailed description
This clinical study is a phase II randomized trial for patients with an acute extensive reperfunded myocardial infarction who undergo coronary artery revascularization with sirolimus coated stents. The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF). The investigational follow-up will be at 30 days, 4 and 9 months.Effectiveness of the therapies on neomyogenesis will be measured by Magnetic Resonance Imaging analysis of left ventricular size and global and regional function and the myocardial viability.The impact of the therapies on stent re-endothelialization and restenosis will be analysed by angiography and intracoronary ultrasounds at 30 days and 9 months. The impact of the different treatments on neoangiogenesis will be measured by infarct related artery intracoronary study of the evolution of coronary flow reserve. Also, it will be measured the haematopoietic precursors kinetic in the different treatment branches.
- Conditions
- Reperfused Acute Myocardial Infarction
- Being tested
- Granulocite Colony Stimulating Factor treatment (G-CSF), Bone marrow mononuclear cells
- Keywords
- Reperfusion, acute myocardial infarction, stem cell therapy, GCSF, bone marrow mononuclear cells, magnetic resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocite Colony Stimulating Factor treatment (G-CSF)Other
G-CSF will be administered at a dose of 10 mcg/kg/day. The administration begins at the first 24 hours post-reperfusion, remaining for 5 days
Bone marrow mononuclear cellsOther
Bone marrow mononuclear cells will be isolated with a Ficoll technique from 50 cc of bone marrow aspiration
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | standard treatment |
| Bone marrow mononuclear progenitors | Experimental | intracoronary transplantation of bone-marrow mononuclear progenitor cells Receives: Other: Bone marrow mononuclear cells |
| GCSF | Experimental | progenitor cells mobilization through Granulocite- Colony Stimulating Factor treatment (G-CSF) Receives: Other: Granulocite Colony Stimulating Factor treatment (G-CSF) |
| GCSF plus bone marrow mononuclear cells | Experimental | combined treatment (intracoronary transplantation plus cell mobilization with G-CSF). Receives: Other: Granulocite Colony Stimulating Factor treatment (G-CSF); Other: Bone marrow mononuclear cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in left ventricular ejection fraction and left ventricular end-systolic volume relative to baseline measured by magnetic resonance
Measured: 9 months
Secondary outcomes (2)
The change in left ventricle end-dyastolyc volume, segment contractility, wall thickness and intravascular ultrasound reendothelization relative to baseline measured by magnetic resonance and other imaging techniques
Measured: 9 months
To determine the safety of the study procedures
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startNov 2005
- Primary completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reperfused 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TECAM Group
- Sponsor type
- Research network
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Investigators
- Francisco Fernandez-Aviles, MD, PhD, Study chair, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984178
- Sponsor's protocol ID
- 2004-005149-36
- Other IDs
- PI041078, 2004
- Acronym
- TECAM2
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
San Roman JA, Sanchez PL, Villa A, Sanz-Ruiz R, Fernandez-Santos ME, Gimeno F, Ramos B, Arnold R, Serrador A, Gutierrez H, Martin-Herrero F, Rollan MJ, Fernandez-Vazquez F, Lopez-Messa J, Ancillo P, Perez-Ojeda G, Fernandez-Aviles F. Comparison of Different Bone Marrow-Derived Stem Cell Approaches in Reperfused STEMI. A Multicenter, Prospective, Randomized, Open-Labeled TECAM Trial. J Am Coll Cardiol. 2015 Jun 9;65(22):2372-82. doi: 10.1016/j.jacc.2015.03.563.
PubMed 26046730
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Intracoronary Delivery of Bone Marrow-derived Stem Cells Versus Stem Cell Mobilisation With GCSF, a Combination of Both Therapies and Conventional Treatment in Patients With Reperfused Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00984178
- Acronym / sponsor ID
- TECAM2 / 2004-005149-36
- Conditions
- Reperfused Acute Myocardial Infarction
- Keywords
- Reperfusion, acute myocardial infarction, stem cell therapy, GCSF, bone marrow mononuclear cells, magnetic resonance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- TECAM GroupResearch network
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Study start
- Nov 2005
- Primary completion
- Nov 2009 (estimated)
- First posted
- 25 Sep 2009 (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.
The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF).
Detailed description
This clinical study is a phase II randomized trial for patients with an acute extensive reperfunded myocardial infarction who undergo coronary artery revascularization with sirolimus coated stents. The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF). The investigational follow-up will be at 30 days, 4 and 9 months.Effectiveness of the therapies on neomyogenesis will be measured by Magnetic Resonance Imaging analysis of left ventricular size and global and regional function and the myocardial viability.The impact of the therapies on stent re-endothelialization and restenosis will be analysed by angiography and intracoronary ultrasounds at 30 days and 9 months. The impact of the different treatments on neoangiogenesis will be measured by infarct related artery intracoronary study of the evolution of coronary flow reserve. Also, it will be measured the haematopoietic precursors kinetic in the different treatment branches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –standard treatment |
| Bone marrow mononuclear progenitors | Experimental | Other: Bone marrow mononuclear cellsintracoronary transplantation of bone-marrow mononuclear progenitor cells |
| GCSF | Experimental | Other: Granulocite Colony Stimulating Factor treatment (G-CSF)progenitor cells mobilization through Granulocite- Colony Stimulating Factor treatment (G-CSF) |
| GCSF plus bone marrow mononuclear cells | Experimental | Other: Granulocite Colony Stimulating Factor treatment (G-CSF), Other: Bone marrow mononuclear cellscombined treatment (intracoronary transplantation plus cell mobilization with G-CSF). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 75 years
- Acute myocardial infarction with the following characteristics:
- Akynesis or hypokinesis in infarct-related artery area without contractility abnormalities in the rest of areas.
- Pharmacological, mechanical or both type reperfusions (facilitated angioplasty) with evidence of normal infarcted area epicardial flow (TIMI grade 3) in the first 24 hours after the beginning of the symptoms
- Successful repair of the infarct-related artery (residual post-stenting stenosis < 30% by visual estimation with epicardial normal flow [grade 3] in the first 24 hours after the beginning of the symptoms or lack of significant residual lesions evidence (<50% visual estimation) in infarct-related artery.
Key exclusion criteria (19 listed)
- The presence of cardiogenic shock defined as sustained systolic blood pressure less than 90 mm Hg, with no response to fluids or systolic blood pressure less than 100 mm Hg with vasopressors (in absence of bradycardia)
- Suspicion or evidence of infarct mechanical complication
- History of sustained ventricular tachycardia or atrial fibrillation
- Patient with cardiac defibrillator or candidate for its potential implantation.
- Investigational drug treatment in the previous 4 weeks
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 |
|---|---|---|
| Granulocite Colony Stimulating Factor treatment (G-CSF)G-CSF will be administered at a dose of 10 mcg/kg/day. The administration begins at the first 24 hours post-reperfusion, remaining for 5 days | Other | GCSF, GCSF plus bone marrow mononuclear cells |
| Bone marrow mononuclear cellsBone marrow mononuclear cells will be isolated with a Ficoll technique from 50 cc of bone marrow aspiration | Other | Bone marrow mononuclear progenitors, GCSF plus bone marrow mononuclear cells |
Primary outcome
The change in left ventricular ejection fraction and left ventricular end-systolic volume relative to baseline measured by magnetic resonance
Time frame: 9 months
2 secondary outcomes
The change in left ventricle end-dyastolyc volume, segment contractility, wall thickness and intravascular ultrasound reendothelization relative to baseline measured by magnetic resonance and other imaging techniques
Time frame: 9 months
To determine the safety of the study procedures
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Derived from this study: PubMed 26046730San Roman JA, Sanchez PL, Villa A, Sanz-Ruiz R, Fernandez-Santos ME, Gimeno F, Ramos B, Arnold R, Serrador A, Gutierrez H, Martin-Herrero F, Rollan MJ, Fernandez-Vazquez F, Lopez-Messa J, Ancillo P, Perez-Ojeda G, Fernandez-Aviles F. Comparison of Different Bone Marrow-Derived Stem Cell Approaches in Reperfused STEMI. A Multicenter, Prospective, Randomized, Open-Labeled TECAM Trial. J Am Coll Cardiol. 2015 Jun 9;65(22):2372-82. doi: 10.1016/j.jacc.2015.03.563.
- Webmail of the TECAM groupLink provided by the sponsor.
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.
Francisco Fernandez-Aviles, MD, PhD study chair
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Granulocite Colony Stimulating Factor treatment (G-CSF) and Bone marrow mononuclear cells in people with Reperfused Acute Myocardial Infarction, run by TECAM Group at 1 site in Spain.
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 9 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro L Sanchez, MD, PhD (34-915865882, pedrolsanchez@secardiologia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in left ventricular ejection fraction and left ventricular end-systolic volume relative to baseline measured by magnetic resonance (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00984178, which also lists 1 linked publication.
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 2 Feb 2010.