Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction (TECAM2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by TECAM Group.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hospital General Universitario Gregorio Marañon
Information provided by:
TECAM Group
ClinicalTrials.gov Identifier:
NCT00984178
First received: September 24, 2009
Last updated: February 1, 2010
Last verified: September 2009
  Purpose

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).


Condition Intervention Phase
Reperfused Acute Myocardial Infarction
Other: Granulocite Colony Stimulating Factor treatment (G-CSF)
Other: Bone marrow mononuclear cells
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by TECAM Group:

Primary Outcome Measures:
  • The change in left ventricular ejection fraction and left ventricular end-systolic volume relative to baseline measured by magnetic resonance [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To determine the safety of the study procedures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2005
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
standard treatment
Experimental: Bone marrow mononuclear progenitors
intracoronary transplantation of bone-marrow mononuclear progenitor cells
Other: Bone marrow mononuclear cells
Bone marrow mononuclear cells will be isolated with a Ficoll technique from 50 cc of bone marrow aspiration
Experimental: GCSF
progenitor cells mobilization through Granulocite- Colony Stimulating Factor treatment (G-CSF)
Other: 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
Experimental: GCSF plus bone marrow mononuclear cells
combined treatment (intracoronary transplantation plus cell mobilization with G-CSF).
Other: 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: Bone marrow mononuclear cells
Bone marrow mononuclear cells will be isolated with a Ficoll technique from 50 cc of bone marrow aspiration

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984178

Contacts
Contact: Pedro L Sanchez, MD, PhD 34-915865882 pedrolsanchez@secardiologia.es
Contact: Francisco Fernández-Aviles, MD, PhD 34-915865882 faviles@secardiologia.es

Locations
Spain
Hospital Universitario de Valladolid Recruiting
Valladolid, Spain, 47002
Contact: Alberto San Roman, MD, PhD    34-665399285    asanroman@secardiologia.es   
Principal Investigator: Alberto San Roman, MD, PhD         
Sponsors and Collaborators
TECAM Group
Hospital General Universitario Gregorio Marañon
Investigators
Study Chair: Francisco Fernandez-Aviles, MD, PhD Hospital General Universitario Gregorio Marañón
  More Information

Additional Information:
No publications provided

Responsible Party: Francisco Fernández-Avilés, TECAM
ClinicalTrials.gov Identifier: NCT00984178     History of Changes
Other Study ID Numbers: 2004-005149-36, PI041078
Study First Received: September 24, 2009
Last Updated: February 1, 2010
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ministry of Health

Keywords provided by TECAM Group:
Reperfusion
acute myocardial infarction
stem cell therapy
GCSF
bone marrow mononuclear cells
magnetic resonance

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014