UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	Phase I/IIa single-arm open-label study of intravenous HUCV002-01 in patients with chronic heart failure
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
Scientific Title:Acronym	Phase I/IIa single-arm open-label study of intravenous HUCV002-01 in patients with chronic heart failure
Region	Japan

Condition
Condition	Chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	The rate of adverse events
Key secondary outcomes	The rate of cell processing failure Assessment of cardiac function Evaluation of exercise tolerability Clinical events due to the progression of heart failure

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key 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
Key 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.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Tsutsui
Organization	Kyushu University Hospital
Division name	Cardiology
Zip code
Address	3-1-1 Maidashi,Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5357
Email	htsutsui@cardiol.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomomi Ide
Organization	Kyushu University Hospital
Division name	Cardiology
Zip code
Address	3-1-1 Maidashi,Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5357
Homepage URL
Email	tomomi_i@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	九州大学病院（福岡県）、北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 31 Day
Date of IRB	2018 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 12 Month 03 Day
Last follow-up date	2019 Year 11 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 26 Day
Last modified on	2020 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039469