Unique ID issued by UMIN | UMIN000035004 |
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Receipt number | R000039469 |
Scientific Title | Phase I/IIa investigator-initiated multicenter single-arm open-label study of the safety and efficacy of intravenous HUCV002-01 in patients with chronic heart failure |
Date of disclosure of the study information | 2018/12/03 |
Last modified on | 2020/11/26 18:52:46 |
Phase I/IIa investigator-initiated multicenter single-arm open-label study of the safety and efficacy of intravenous HUCV002-01 in patients with chronic heart failure
Phase I/IIa single-arm open-label study of intravenous HUCV002-01 in patients with chronic heart failure
Phase I/IIa investigator-initiated multicenter single-arm open-label study of the safety and efficacy of intravenous HUCV002-01 in patients with chronic heart failure
Phase I/IIa single-arm open-label study of intravenous HUCV002-01 in patients with chronic heart failure
Japan |
Chronic heart failure
Cardiology |
Others
NO
To assess the safety of HUCV002-01, a-GalCer expressed dendritic cells derived from autologous monocytes from patients with chronic heart failure within 24 weeks after the administration of the first dose
Safety,Efficacy
Exploratory
Phase I,II
The rate of adverse events
The rate of cell processing failure
Assessment of cardiac function
Evaluation of exercise tolerability
Clinical events due to the progression of heart failure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
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 will be treated with the two doses of intravenous HUCV002-1 (Day1,7) as inpatients. The safety and efficacy of HUCV002-1 will be evaluated within 24 weeks after the first dose.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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.
5
1st name | |
Middle name | |
Last name | Hiroyuki Tsutsui |
Kyushu University Hospital
Cardiology
3-1-1 Maidashi,Higashi-ku, Fukuoka 812-8582, Japan
092-642-5357
htsutsui@cardiol.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Tomomi Ide |
Kyushu University Hospital
Cardiology
3-1-1 Maidashi,Higashi-ku, Fukuoka 812-8582, Japan
092-642-5357
tomomi_i@cardiol.med.kyushu-u.ac.jp
Kyushu University Hospital
AMED
Japanese Governmental office
Japan
NO
九州大学病院(福岡県)、北海道大学病院(北海道)
2018 | Year | 12 | Month | 03 | Day |
Unpublished
Completed
2018 | Year | 08 | Month | 31 | Day |
2018 | Year | 10 | Month | 11 | Day |
2018 | Year | 12 | Month | 03 | Day |
2019 | Year | 11 | Month | 27 | Day |
2018 | Year | 11 | Month | 26 | Day |
2020 | Year | 11 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039469
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