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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04945018
Other study ID # HS-001-01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 19, 2022
Est. completion date January 31, 2026

Study information

Verified date February 2024
Source Heartseed Inc.
Contact Heartseed Inc.
Phone 0363801068
Email contact@heartseed.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this clinical study is to evaluate the safety and efficacy of HS-001 CS transplanted into severe heart failure patients with underlying ischemic heart disease for 26 weeks after transplantation.


Description:

This is a multicenter, open-label, two-group dose-escalation, phase I/II study in 10 severe heart failure patients (five in the low-dose group and five in the high-dose group) with underlying ischemic heart disease. After screening period is completed, subjects undergo HS-001 CS transplantation. After transplantation, subjects take immunosuppressant and have efficacy/safety assessments.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date January 31, 2026
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Patients with resting left ventricular ejection fraction (LVEF) ?40% based on institutional assessment on either screening cardiac MRI or echocardiographic assessment - New York Heart Association (NYHA) cardiac function classification of grade II or higher at screening - Other Criteria apply, please contact the investigator Exclusion Criteria: - Patients screened less than 1 month after the onset of myocardial infarction - Patients with congenital heart disease, or cardiac sarcoidosis - Other Criteria apply, please contact the investigator

Study Design


Intervention

Biological:
HS-001 CS
Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension
Device:
HS-001-D needle, HS-001-D Adaptor
Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors

Locations

Country Name City State
Japan St. Marianna University Hospital Kawasaki
Japan Saitama Medical University International Medical Center Saitama
Japan Juntendo University Hospital Tokyo
Japan Nihon University Itabashi Hospital Tokyo
Japan The University of Tokyo Hospital Tokyo
Japan Tokyo Medical and Dental University Medical Hospital Tokyo
Japan Tokyo Metropolitan Geriatric Medical Center Tokyo
Japan Tokyo Women's Medical University Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Heartseed Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability Adverse events and safety in the 26 weeks after HS-001 CS transplantation 26 weeks post-transplant
Secondary Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-001 CS transplantation 26 weeks and 52 weeks post-transplant
Secondary Myocardial wall motion evaluation in Echocardiography Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks after HS-001 CS transplantation 26 weeks and 52 weeks post-transplant
Secondary Myocardial blood flow in SPECT Myocardial blood flow in the 26 weeks and 52 weeks after HS-001 CS transplantation 26 weeks and 52 weeks post-transplant
Secondary Myocardial viability in SPECT Myocardial viability in the 26 weeks and 52 weeks after HS-001 CS transplantation 26 weeks and 52 weeks post-transplant
Secondary 6-minute walk distance 6-minute walk distance in the 26 weeks and 52 weeks after HS-001 CS transplantation 26 weeks and 52 weeks post-transplant
Secondary Kansas City Cardiomyopathy Questionnaire (KCCQ) Kansas City Cardiomyopathy Questionnaire in the 26 weeks and 52 weeks after HS-001 CS transplantation 26 weeks and 52 weeks post-transplant
Secondary 5-level EQ-5D version (EQ-5D-5L) 5-level EQ-5D version (EQ-5D-5L) in the 26 weeks and 52 weeks after HS-001 CS transplantation 26 weeks and 52 weeks post-transplant
Secondary N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in the 26 weeks and 52 weeks after HS-001 CS transplantation 26 weeks and 52 weeks post-transplant
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