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 1

• Conditions: Chronic heart failure

• Registration Number: JPRN-UMIN000035004
• Lead Sponsor: Kyushu University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-03
• Study Completion: 2019-11-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of adverse events

Secondary Outcome Measures

Name	Time	Method
The rate of cell processing failure Assessment of cardiac function Evaluation of exercise tolerability Clinical events due to the progression of heart failure