This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. The research process is as follows: 1. Twenty eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into CABG group (n=10) or CABG + stem cell treatment group (n=10); 2. CABG was performed under general anesthesia in both groups. In the cell therapy group, 1×10\^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG; 3. Use vasoactive drugs and antibiotics to prevent infection one week after surgery. After the operation, before discharge, 1 month, 3 months, 6 months, 12 months after discharge, and once a year thereafter, until the death of the patient. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
In CABG with hUC-MSC treatment group, 1×10\^7 Human Umbilical Cord Mesenchymal Stem Cells were injected at the edge of the myocardial infarction area at 20 points at the same time in CABG
Shanghai East Hospital, Shanghai Tongji University
Shanghai, Shanghai Municipality, China
RECRUITINGLeft ventricular ejection fraction
The change in Left ventricular ejection fraction (LVEF) % after the operation
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular end diastolic volume
The change in Left ventricular end diastolic volume (LVEDV) ml after the operation
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular end systolic volume
The change in Left ventricular end systolic volume (LVESV) ml after the operation
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Stroke volume
The change in Stroke volume (SV) ml after the operation
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular apex four-chamber end systolic diameter
The change in Left ventricular apex four-chamber end systolic diameter (LVESD) mm after the operation
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
6 minutes walking distance
The change in 6 minutes walking distance m after the operation
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF
The change in THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF after the operation
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
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