The study is designed to assess the safety and efficacy of allogeneic human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted into patients with chronic ischemic cardiomyopathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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.
Patients underwent Coronary Artery Bypass Surgery (CABG) with 10\^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) injecting in the infarct region.
Patients underwent CABG alone.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Incidence of treatment-emergent adverse events
Adverse events (AEs), serious adverse events (SAEs) and changes in vital signs, electrocardiogram (ECG) and laboratory values were measured.
Time frame: up to 24 months after surgery
Myocardial blood flow
Change in myocardial blood flow evaluated by Cardiac magnetic resonance imaging (MRI).
Time frame: 1, 3, 6, 12 and 24 months
Left ventricle ejection fraction (LVEF)
Change in LVEF as measured by ultrasonic cardiogram (UCG) and Cardiac magnetic resonance imaging (MRI).
Time frame: 1, 3, 6, 12 and 24 months
Infarct size
Change in infarct size evaluated by Cardiac magnetic resonance imaging (MRI).
Time frame: 1, 3, 6, 12 and 24 months
New York Heart Association (NYHA) Functional Classification
Change in clinical symptoms evaluated by NYHA.
Time frame: 1, 3, 6, 12 and 24 months
Canadian Cardiovascular Society (CCS) Angina Grading Scale
Change in clinical symptoms evaluated by CCS.
Time frame: 1, 3, 6, 12 and 24 months
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