Targeting patients with severe ischemic cardiomyopathy, the purpose of this study is as follows: to confirm short-term efficacy by observing changes and transitions in cardiac function and clinical symptoms compared with each patient's baseline (before and after comparison) by human iPS cell-derived cardiomyocyte sheet transplantation, and to evaluate the safety and tolerability including the combined use of immunosuppressants.
The objective of this study is to confirm the efficacy and safety of a human (allogeneic) iPS cell-derived cardiomyocyte sheet in combination with an immunosuppressant for ischemic cardiomyopathy patients. The primary evaluation items will be improvement of left ventricular systolic function (LVEF) for efficacy, and safety will be assessed by blood tests, general laboratory tests, and other safety-related evaluations. Secondary evaluation items are NYHA functional evaluation, left ventricular remodeling evaluation by echocardiography, hemodynamic evaluation, physical activity function evaluation such as 6MWD and SAS, QOL, and exercise tolerance evaluation by questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Transplantation
Osaka University Hospital
Suita, Osaka, Japan
RECRUITINGThe number of patients with improved LVEF
The number of patients with improved LVEF by echocardiography 26 weeks postoperatively compared with preoperatively.
Time frame: 26 weeks
Incidence of adverse events and defects [Safety and Tolerability]
Regarding adverse events and side effects (of the adverse events, those whose causal relationship with the clinical trial product is determined to be other than "not related" will be treated as side effects.) the number of occurrences and the number of occurrence examples by event and severity will be obtained.
Time frame: From postoperative to the end of the observation period (52 weeks)
Incidence of serious adverse events [Safety and Tolerability]
Regarding serious adverse events, the number of occurrences and the number of occurrence examples by event and severity will be obtained.
Time frame: From postoperative to the end of the observation period (52 weeks)
Incidence of abnormal vital signs [Safety and Tolerability]
Regarding changes in vital signs(Body temperature, blood pressure (systolic, diastolic), and pulse rate), summary statistics and changes at each measurement time point will be obtained.
Time frame: Before surgery, 7 days, 14 days, 4 weeks, 13 weeks, 26 weeks, 52 weeks
Incidence of abnormal general blood tests [Safety and Tolerability]
Regarding changes in general blood tests(WBC, RBC, Hb, Ht, PLT), summary statistics and changes at each measurement time point will be obtained.
Time frame: Before surgery, 1 days, 7 days, 14 days, 4 weeks, 13 weeks, 26 weeks, 52 weeks
Incidence of abnormal blood biochemical tests [Safety and Tolerability]
Regarding changes in blood biochemistry tests(AST(GOT), ALT(GPT), LDH, ALP, BUN, Cre, UA, TG, T-Cho, LDL-Cho, Alb, CK, CK-MB, electrolytes (Na, K, Cl, Ca, iP, Mg), CRP, blood sugar), summary statistics and changes at each measurement time point will be obtained.
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Time frame: Before surgery, 1 days, 7 days, 14 days, 4 weeks, 13 weeks, 26 weeks, 52 weeks
Incidence of abnormal tumor marker tests [Safety and Tolerability]
Regarding changes in tumor marker tests(AFP, CA19-9, CEA, hCG), summary statistics and changes at each measurement time point will be obtained.
Time frame: Screening, 13 weeks, 26 weeks, 52 weeks
Incidence of cardiac function clinical events such as death and hospitalization [Safety and Tolerability]
With respect to the incidence of cardiac function clinical events such as death and hospitalization, the number of cases in which the causes of death are related to heart disease and those unrelated to heart disease will be determined for cases of death.
Time frame: From postoperative to the end of the observation period (52 weeks)
Number of Responder patients 26 and 52 weeks after transplantation of this product
To comprehensively evaluate the efficacy of this product transplantation
Time frame: 26 and 52 weeks
Contraction function of the entire left ventricle
To comprehensively evaluate the efficacy of this product transplantation
Time frame: 26 weeks
Left ventricular remodeling (LVESVI)
Changes in left ventricular end systolic volume index (LVESVI) (echocardiography, CT (if available))
Time frame: 26 weeks
Left ventricular remodeling (LVEDVI)
Changes in left ventricular end-diastolic volume index (LVEDVI) (echocardiography, CT (if available))
Time frame: 26 weeks
New York Heart Association functional classification
Evaluation of the following changes and transitions before and 26 and 52 weeks after surgery. Class I to Class IV, the more severe, the higher the number.
Time frame: Before surgery, 26 weeks, 52 weeks
Specific Activity Scale (SAS)
Evaluation of the following changes and transitions before and 26 and 52 weeks after surgery. This is a quantitative evaluation of the subjective symptoms of heart failure from the viewpoint of exercise tolerance. List various daily activities for which exercise intensity \[oxygen uptake or metabolic equivalents (METs)\] is almost known in advance, ask whether they are possible, and exercise with the lowest activity level that was not possible is evaluated value. The higher the number, the better the condition.
Time frame: Before surgery, 26 weeks, 52 weeks
The Minnesota Living with Heart Failure Questionnaire
Evaluation of the following changes and transitions before and 26 and 52 weeks after surgery. The lower the number, the better the condition.
Time frame: Before surgery, 26 weeks, 52 weeks
36-Item Short Form Survey (SF-36)
Evaluation of the following changes and transitions before and 26 and 52 weeks after surgery. The higher the number, the better the condition.
Time frame: Before surgery, 26 weeks, 52 weeks
6-minute walking distance
Evaluation of the following changes and transitions before and 26 and 52 weeks after surgery. The higher the number, the better the condition.
Time frame: Before surgery, 26 weeks, 52 weeks
Brain natriuretic peptide (BNP)
Evaluation of the following changes and transitions.
Time frame: Before surgery, 1 days, 7 days, 14 days, 4 weeks, 13 weeks, 26 weeks, 52 weeks
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Evaluation of the following changes and transitions.
Time frame: Before surgery, 1 days, 7 days, 14 days, 4 weeks, 13 weeks, 26 weeks, 52 weeks
Exercise tolerance (VO2max)
Evaluation of the following changes and transitions before and 26 and 52 weeks after surgery. Measure the maximum oxygen uptake (VO2max) using the bicycle ergometer.
Time frame: Before surgery, 26 weeks, 52 weeks
Exercise tolerance (AT)
Evaluation of the following changes and transitions before and 26 and 52 weeks after surgery. Measure the anaerobic metabolism threshold (AT) using the bicycle ergometer.
Time frame: Before surgery, 26 weeks, 52 weeks
Exercise tolerance (VE/VCO2)
Evaluation of the following changes and transitions before and 26 and 52 weeks after surgery. Measure the expiratory minute volume (VE)/the CO2 uptake (VCO2) using the bicycle ergometer.
Time frame: Before surgery, 26 weeks, 52 weeks
Cumulative number of rejections that occurred during the observation period
Cumulative number of rejections from transplant up to 26 weeks after surgery
Time frame: 26 weeks