Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT01946048|
Recruitment Status : Unknown
Verified October 2013 by Quanhai Li, Hebei Medical University.
Recruitment status was: Not yet recruiting
First Posted : September 19, 2013
Last Update Posted : October 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Cardiomyopathy||Biological: mesenchymal stem cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2014|
Experimental: mesenchymal stem cells
Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells.
Biological: mesenchymal stem cells
Procedure: Selected patients were randomly divided into a cell therapy group and a control group.
Umbilical Cord Blood Derived Mesenchymal Stem Cells at a dose of 150-250 million.
- The examination of heart function [ Time Frame: Post cell transplantation: 1, 3, 6 months ]Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.
- all-cause mortality [ Time Frame: Post cell transplantation: one year ]
- all-cause morbidity [ Time Frame: Post cell transplantation: one year ]
- major adverse cardiac and cerebrovascular events [ Time Frame: Post cell transplantation: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946048
|the First Hospital of Hebei Medical University|
|Shijiazhuang, Hebei, China, 050000|
|Study Chair:||Baoyong Yan, Doctor||The First Hospital of Hebei Medical University|
|Study Director:||Gang Liu, Doctor||The First Hospital of Hebei Medical University|
|Principal Investigator:||Guoping Ma, Master||The First Hospital of Hebei Medical University|
|Principal Investigator:||Jun Zhang, Master||The First Hospital of Hebei Medical University|