Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT02635464|
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Ischemic Cardiomyopathy||Biological: hUC-MSCs+Injectable collagen scaffold+CABG Biological: hUC-MSCs+CABG Procedure: CABG||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (hUC-MSCs) With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
|Experimental: hUC-MSCs+Injectable collagen scaffold+CABG||
Biological: hUC-MSCs+Injectable collagen scaffold+CABG
Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) in collagen scaffold injecting in the infarct region.
|Active Comparator: hUC-MSCs+CABG||
Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) injecting in the infarct region.
|Active Comparator: CABG||
Patients underwent CABG alone.
- Incidence of treatment-emergent adverse events [ Time Frame: up to 24 months after surgery ]Adverse events (AEs), serious adverse events (SAEs) and changes in vital signs, electrocardiogram (ECG) and laboratory values were measured.
- Myocardial blood flow [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in myocardial blood flow evaluated by Cardiac magnetic resonance imaging (MRI).
- Left ventricle ejection fraction (LVEF) [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in LVEF as measured by ultrasonic cardiogram (UCG) and Cardiac magnetic resonance imaging (MRI).
- Infarct size [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in infarct size evaluated by Cardiac magnetic resonance imaging (MRI).
- New York Heart Association (NYHA) Functional Classification [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in clinical symptoms evaluated by NYHA.
- Canadian Cardiovascular Society (CCS) Angina Grading Scale [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in clinical symptoms evaluated by CCS.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635464
|Contact: Dongjin Wang, M.D.||86-25-83106666|
|Contact: Sufang Han, Ph.D.||firstname.lastname@example.org|
|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School||Recruiting|
|Nanjing, Jiangsu, China, 210008|
|Contact: Dongjin Wang, M.D. 86-25-83106666|
|Contact: Qiang Wang 86-25-83106666 ext 60751 email@example.com|
|Principal Investigator:||Jianwu Dai, Ph.D.||Chinese Academy of Sciences|