Phase IIb investigator-initiated multicenter study of the efficacy and safety of intravenous HUCV002-01 in patients with chronic heart failure (continuous study)

JRCT ID: jRCT2073220002

Registered date:12/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: chronic heart failure
• Date of first enrollment: 12/04/2022
• Target sample size: 15
• Study type: Interventional

Intervention(s)

Peripheral monocytes and plasma will be collected from patients by apheresis. The collected monocytes and plasma will be transported to the manufacturing facility.
The patient will be treated with intravenous HUCV002-01(1.0 x 10^9 cells/m^2).

Outcome(s)

• Primary Outcome: Change in left ventricular ejection fraction from baseline to 24 weeks

Secondary Outcome

Assessment of cardiac function
Evaluation of exercise tolerability
Clinical events due to the progression of heart failure
adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

1) Patients enrolled in the HUCV002-01-02 study who were assigned to the standard treatment arm
2) Patients diagnosed with chronic heart failure
3) 20 years old or older, 90 years or younger at the time of informed consent
4) LVEF<40% by ECHO performed within 28 days before the enrollment
5) NYHA class II-IV, AND, no changes at least 4 weeks prior to the enrolment
6) BNP>=100 pg/mL, OR, NT-proBNP>=400 pg/mL
7) Refractory to standard medical therapy on JCS/JHFS 2021 Guideline Focused Update on Diagnosis and Treatment of Acute and Chronic Heart Failure with no clinical improvement
8) Patients who has ability to understand and sign the informed consent

Exclude criteria

1)Chronic heart failure dues to operable valvular disease, congenital cardiac disease or coronary arterial 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 (CABG, 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 or ALT > ULN x3
b)Renal dysfunction: eGFR < 15 mL/min/1.73m^2
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 m^2 (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 who are taking amiodarone or have taken it in the past.
23)SpO2 (room air) < 93% within 28 days before the enrollment.
24)Patients with severe lung disease or a history of non-infectious interstitial lung disease requiring steroid therapy.
25)Patients whom the PI or investigators decided as inappropriate for the study.

Related Information

• Primary Sponsor: Tsutsui Hiroyuki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED),MEDINET Co., Ltd.