HFrEF due to ischemic heart disease or dilated cardiocardio myopathy heart failure with reduced ejection fraction, Ischemic heart disease, dilated cardiocardio myopathy, Heart Failure,
Conditions
Interventions
Patients with ischemic heart disease:
Cell suspension containing 150 million cells / body is divided and administered (transplanted) into up to 15 doses (sites) within the myocardial layer in areas of
Sponsors
Kaneko Takehiko
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 20 to 80 years or younger at the time of informed consent atients with symptomatic heart failure due to reduced left ventricular ejection fraction Patients whose cause of heart failure is ischemic heart disease or dilated cardiomyopathy Subjects with a resting left ventricular ejection fraction (LVEF) of 0.20 to 0.40 or less as assessed by echocardiography at screening. New York Heart Association (NYHA) cardiac performance class at screening for II or III Individuals with NT-proBNP 600 pg/mL to 5000 pg/mL at screening
Exclusion criteria
Exclusion criteria: Those who have pacemakers, ICD, CRT-D, or other devices inserted into the heart Patients with heart failure due to hypertrophic cardiomyopathy (including dilated phase), restrictive cardiomyopathy, amyloidosis, Takotsubo cardiomyopathy, congenital heart disease, cardiac sarcoidosis, or constrictive pericarditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart function QOL | — |
Contacts
Public Contactdesk inquiry
Heartseed Inc
Outcome results
None listed