Trial record 1 of 1 for:
NCT01753440
Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01753440 |
Recruitment Status :
Completed
First Posted : December 20, 2012
Last Update Posted : May 7, 2019
|
Sponsor:
AHEPA University Hospital
Information provided by (Responsible Party):
Kyriakos Anastasiadis, AHEPA University Hospital
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | December 18, 2012 | |||
First Posted Date ICMJE | December 20, 2012 | |||
Last Update Posted Date | May 7, 2019 | |||
Actual Study Start Date ICMJE | November 2012 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
|
|||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy | |||
Official Title ICMJE | 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. | |||
Brief Summary | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE | Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).
|
|||
Study Arms ICMJE | Stem cells implantation
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.
Intervention: Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
|
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
11 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date ICMJE | December 2014 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Greece | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01753440 | |||
Other Study ID Numbers ICMJE | AHEPA_CTL_01 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Kyriakos Anastasiadis, AHEPA University Hospital | |||
Original Responsible Party | Kyriakos Anastasiadis, AHEPA University Hospital, Associate Professor Kyriakos Anastasiadis | |||
Current Study Sponsor ICMJE | AHEPA University Hospital | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | AHEPA University Hospital | |||
Verification Date | May 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |