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

Phase 2

• Conditions: D006333; heart failure, cardiomyopathy; chronic heart failure

• Registration Number: JPRN-jRCT2073210116
• Lead Sponsor: Tsutsui Hiroyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1)Patients diagnosed with chronic heart failure
2)20 years old or older, 90 years or younger at the time of informed consent
3)LVEF<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, OR, NT-proBNP>=400 pg/mL
6)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
7)Patients who has ability to understand and sign the informed consent

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in left ventricular ejection fraction from baseline to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of cardiac function<br>Evaluation of exercise tolerability<br>Clinical events due to the progression of heart failure<br>adverse events