Chronic heart failure
Conditions
Interventions
Peripheral monocytes will be collected from patients by apheresis on 9 to 58 before the first dose of HUCV002-1. The collected monocytes will be cultured and HUCV002-1 will be produced. The patient wi
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed with chronic heart failure 2)20 years old or older, 80 years or younger at the time of informed consent 3)LVFT<40% by ECHO performed within 28 days before the enrollment 4)NYHA class II-IV, AND, no changes at least 4 weeks prior to the enrolment 5)BNP>=100 pg/mL (except for patients with NYHA class II) 6)Refractory to standard medical therapy on Guidelines for Acute/Chronic heart failure (2017) with no clinical improvement 7)Patients who has ability to understand and sign the informed consent
Exclusion criteria
Exclusion criteria: Those who has any of the following at the time of enrollment should be excluded. 1)Chronic heart failure dues to operable valvular disease or congenital cardiac disease 2)Awaiting cardiac transplant 3)Acute myocardial infarction within 28 days prior to the enrollment 4)Cerebrovascular disease within 28 days before the enrollment 5)Coronary artery revascularization (CAVG, PCI) was performed or planned within 3 months before getting consent or during the clinical study 6)New treatments for cardiac failure was started within 3 months before the enrollment 7)Patients with malignancy or history of malignant diseases within 1 year prior to the study (Except for those who had cured carcinoma in situ or intramucosal carcinoma) 8)Uncontrolled hypertension (systemic BP>160mmHg or diastolic BP>100mmHg) 9)Symptomatic hypotension 10)Autoimmune disease 11)Any of the following within 7 days before the registration a)Hepatic dysfunction: AST > 90 U/L or ALT (male) > 126 U/L, (female) >69 U/L b)Renal dysfunction: eGFR < 15 mL/min/1.73m2 c)Platelet counts < 100 x 10^3/uL d)Hb < 9.0 g/dL 12)Positive for any of HBV, HCV, HIV, HTLV1 or syphilis within 56 days before the enrollment 13)Those who has history or viral hepatitis 14)Patients with uncontrolled active infection 15)Allergic to streptomycin or gentamicin 16)Allergic to animals (pig, sheep, cow) or cows milk 17)Patient who needs systemic steroid or immunosuppressive drugs 18)BSA > 2.0 m2 (Du Bois) 19)Functional gait disorder 20)Pregnant, lactating, or possible pregnant female. Female who wants to become pregnant or male who wants his partner to become pregnant. Those who refuses contraception during the study. 21)Those who participated in other clinical studies within 28 days prior to getting the informed consent. Those who plans to participate in other clinical studies during this study. 22)Patients whom the PI or investigators decided as inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of cell processing failure Assessment of cardiac function Evaluation of exercise tolerability Clinical events due to the progression of heart failure | — |
Countries
Japan
Contacts
Public ContactTomomi Ide
Kyushu University Hospital Cardiology
Outcome results
None listed