Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.
Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study. Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention. Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects. The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months. Clinical results will be analyzed after completion of 12 months of followup.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10\^7)
Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, China
RECRUITINGNumber and nature of adverse events
Evidence for new clinical/biological abnormalities.
Time frame: Within the first year after intracoronary infusion
Incidence of major adverse coronary events (MACE)
Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure.
Time frame: Within the first year after intracoronary infusion
Exercise Time and Level
Exercise time and level as assessed via six minute walk test.
Time frame: Post cell transplantation: 1, 3, 6, 12 months
Quantify myocardium perfusion measured by SPECT
The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 6 and 12 months in perfusion images, as measured by SPECT.
Time frame: Post cell transplantation: 6, 12 months
Assessment of heart function by left ventricular ejection fraction
Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation.
Time frame: Post cell transplantation: 1, 3, 6,12 months
Clinical Improvement in NYHA Classification
The NYHA scale ranges from 1 (best)"Mild- no limitation of physical activity due to heart failure" to 4 (worst) "Severe-Unable to carry out any physical activity without discomfort due to heart failure".
Time frame: 1 year
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