A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)

Heart Failure Clinical Trial

— LAPiS  

Official title:

A Phase I/II Study of Human Induced Pluripotent Stem (iPS) Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Severe Heart Failure, Secondary to Ischemic Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945018
• Other study ID #: HS-001-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

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