ClinicalTrials.gov

History of Changes for Study: NCT01753440
Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy
Latest version (submitted May 3, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 19, 2012 Nothing (earliest Version on record)
2 November 27, 2013 Study Status
3 May 3, 2019
Recruitment Status
, Study Status, Outcome Measures, Arms and Interventions, Contacts/Locations, Study Design, Study Description and Sponsor/Collaborators
Comparison Format:

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Changes (Side-by-Side) for Study: NCT01753440
December 19, 2012 (v1) -- May 3, 2019 (v3)

Changes in: Study Status, Outcome Measures, Arms and Interventions, Contacts/Locations, Study Design, Study Description and Sponsor/Collaborators

Study Identification
Unique Protocol ID: AHEPA_CTL_01 AHEPA_CTL_01
Brief Title: Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy
Official Title: Study on the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Implantation Combined With Bypass Grafting in Patients With Coronary Artery Disease and Ischemic Cardiomyopathy. Study on the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Implantation Combined With Bypass Grafting in Patients With Coronary Artery Disease and Ischemic Cardiomyopathy.
Secondary IDs:
Study Status
Record Verification: December 2012 May 2019
Overall Status: Recruiting Completed
Study Start: November 2012 November 2012
Primary Completion: December 2014 [Anticipated ] September 2014 [Actual ]
Study Completion: December 2015 [Anticipated ] December 2014 [Actual ]
First Submitted: December 18, 2012 December 18, 2012
First Submitted that
Met QC Criteria:
December 19, 2012 December 19, 2012
First Posted: December 20, 2012 [Estimate ] December 20, 2012 [Estimate ]
Last Update Submitted that
Met QC Criteria:
December 19, 2012 May 3, 2019
Last Update Posted: December 20, 2012 [Estimate ] May 7, 2019 [Actual ]
Sponsor/Collaborators
Sponsor: AHEPA University Hospital AHEPA University Hospital
Responsible Party: Principal Investigator
Investigator: Kyriakos Anastasiadis
Official Title: Associate Professor Kyriakos Anastasiadis
Affiliation: AHEPA University Hospital
Principal Investigator
Investigator: Kyriakos Anastasiadis
Official Title: Professor Kyriakos Anastasiadis
Affiliation: AHEPA University Hospital
Collaborators:
Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No No
Study Description
Brief Summary: The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting. The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of a novel mesenchymal precursor cell type (iMP) in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting.
Detailed Description: This study aims to investigates in situ cardiac regeneration utilizing precision delivery of a novel mesenchymal precursor cell type (iMP) during coronary artery bypass surgery (CABG) in patients with ischemic cardiomyopathy (LVEF < 40 %). Preoperative scintigraphy imaging (SPECT) will be used to identify hibernating myocardium not suitable for conventional myocardial revascularization for iMP implantation. iMP cells will be implanted intramyocardially in predefined viable peri-infarct areas that show poor perfusion, which could not be grafted due to poor target vessel quality. Postoperatively, SPECT will be used to identify changes in scar area.
Conditions
Conditions: Coronary Artery Disease
Ischemic Cardiomyopathy
Coronary Artery Disease
Ischemic Cardiomyopathy
Keywords: coronary artery disease
heart failure
stem cells implantation
coronary artery disease
heart failure
stem cells implantation
Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 2/Phase 3Phase 2
Interventional Study Model: Single Group Assignment Single Group Assignment
Number of Arms: 11
Masking: None (Open Label)None (Open Label)
Allocation: N/AN/A
Enrollment: 30 [Anticipated ] 11 [Actual ]
Arms and Interventions
Arms Assigned Interventions
Active Comparator
Stem cells implantation
Patients with severe coronary artery disease with ischemic cardiomyopathy managed with concomitant coronary artery bypass grafting and intramyocardial administration of allogeneic mensenchymal stem cells. Patients with severe coronary artery disease and chronic ischemic cardiomyopathy with a LVEF ≤40% who are scheduled for elective CABG according to accepted guidelines. Additional criteria include the following: age <75 years, history of myocardial infarction (not less than 14 days before the procedure), LVEF ≤40 % assessed with echocardiography, and a distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization.
Procedure: Intramyocardial implantation of allogeneic of a novel mesenchymal stem precursor cell type (iMP).
Intramyocardial implantation of allogeneic a novel mesenchymal stem precursor cell type (iMP).
Outcome Measures
Primary Outcome Measures:
1. iMP-related adverse events
Major adverse cardiac and cerebrovascular events including death, postoperative myocardial infarction, need for revascularization, stroke, hospitalization for worsening heart failure, myocardial rupture, infectious myocarditis, or sustained ventricular arrhythmias.

[Time Frame: 12 months ]
2. Hypersensitivity
Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)

[Time Frame: 12 months ]
3. Left ventricular ejection fraction
Change in left ventricular ejection fraction assesed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.

[Time Frame: one year ]
4. Myocardial segmental perfusion
change in segmental perfusion as assesed with SPECT after intramyocardial implantation of allogeneic mesenchymal stem cells.

[Time Frame: one year ]
Secondary Outcome Measures:
5. all-cause mortality

[Time Frame: one year ]
Scar reduction
Myocardial scar size reduction assessed with SPECT

[Time Frame: 4 months ]
6. major adverse cardiac and cerebrovascular events

[Time Frame: one year ]
Scar reduction
Myocardial scar size reduction assess with SPECT

[Time Frame: 12 months ]
7. all-cause morbidity

[Time Frame: one year ]
LVEF
Left ventricular ejection fraction

[Time Frame: 12 months ]
8. Change in quality of life
Quality of life evaluated with MLHFQ

[Time Frame: 12 months ]
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age: 75 Years 75 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  • Age from 18 to 75 years
  • Severe coronary artery disease amenable to surgical revascularization according to current guidelines
  • History of acute myocardial infarction at least 14 days previously
  • Left ventricular ejection fraction (LVEF) ≤ 40% as assessed with echocardiography
  • Distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization
  • Patient's informed consent obtained

Exclusion Criteria:

  • Emergency operation
  • Debilitating chronic disease (eg. malignancy or terminal renal failure)
  • Concomitant valve surgery
  • Previous cardiac surgery
  • Malignant ventricular arrhythmias
  • Haematologic disease
  • Woman in reproductive age
  • Severe psychiatric illness

Inclusion Criteria:

  • Age from 18 to 75 years
  • Severe coronary artery disease amenable to surgical revascularization according to current guidelines
  • History of acute myocardial infarction at least 14 days previously
  • Left ventricular ejection fraction (LVEF) ≤ 40% as assessed with echocardiography
  • Distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization
  • Patient's informed consent obtained

Exclusion Criteria:

  • Emergency operation
  • Debilitating chronic disease (eg. malignancy or terminal renal failure)
  • Concomitant valve surgery
  • Previous cardiac surgery
  • Malignant ventricular arrhythmias
  • Haematologic disease
  • Woman in reproductive age
  • Severe psychiatric illness
Contacts/Locations
Central Contact: Polychronis Antonitsis, MD, DSc
Telephone: + 30 2310994871
Email: antonits@auth.gr
Study Officials: Kyriakos Anastasiadis, MD, DSc, FETCS
Principal Investigator
AHEPA University Hospital
Kyriakos Anastasiadis, MD, PhD FETCS
Principal Investigator
AHEPA University Hospital
Locations: GreeceGreece
AHEPA University Hospital
[Recruiting]
Thessaloniki, Greece, 546 36
Contact: Polychronis Antonitsis, MD, DSc + 30 2310 994871 antonits@auth.gr
Principal Investigator: Polychronis Antonitsis, MD, DSc
AHEPA University Hospital
Thessaloniki, Greece, 546 36
IPDSharing
Plan to Share IPD:
References
Citations: Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow–derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. Erratum in: JAMA. 2013 Aug 21;310(7):750. George, Richard [added]; Lardo, Albert [added]. PubMed 23117550Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow–derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. Erratum in: JAMA. 2013 Aug 21;310(7):750. George, Richard [added]; Lardo, Albert [added]. PubMed 23117550
Anastasiadis K, Antonitsis P, Doumas A, Koliakos G, Argiriadou H, Vaitsopoulou C, Tossios P, Papakonstantinou C, Westaby S. Stem cells transplantation combined with long-term mechanical circulatory support enhances myocardial viability in end-stage ischemic cardiomyopathy. Int J Cardiol. 2012 Mar 22;155(3):e51-3. doi: 10.1016/j.ijcard.2011.07.062. Epub 2011 Aug 17. PubMed 21852003Anastasiadis K, Antonitsis P, Doumas A, Koliakos G, Argiriadou H, Vaitsopoulou C, Tossios P, Papakonstantinou C, Westaby S. Stem cells transplantation combined with long-term mechanical circulatory support enhances myocardial viability in end-stage ischemic cardiomyopathy. Int J Cardiol. 2012 Mar 22;155(3):e51-3. doi: 10.1016/j.ijcard.2011.07.062. Epub 2011 Aug 17. PubMed 21852003
Menasche P. Cardiac cell therapy: lessons from clinical trials. J Mol Cell Cardiol. 2011 Feb;50(2):258-65. doi: 10.1016/j.yjmcc.2010.06.010. Epub 2010 Jun 30. Review. PubMed 20600097Menasche P. Cardiac cell therapy: lessons from clinical trials. J Mol Cell Cardiol. 2011 Feb;50(2):258-65. doi: 10.1016/j.yjmcc.2010.06.010. Epub 2010 Jun 30. Review. PubMed 20600097
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