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

Primary Purpose

Heart Failure, Ischemic Heart Disease

Status

Recruiting

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

HS-001 CS

HS-001-D needle, HS-001-D Adaptor

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Ischemic Heart Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Marianna University HospitalRecruiting
Saitama Medical University International Medical CenterRecruiting
Juntendo University HospitalRecruiting
Nihon University Itabashi HospitalRecruiting
Sakakibara Heart InstituteRecruiting
The University of Tokyo HospitalRecruiting
Tokyo Medical and Dental University Medical HospitalRecruiting
Tokyo Metropolitan Geriatric Medical CenterRecruiting
Tokyo Women's Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

HS-001 Low dose

HS-001 High dose

Arm Description

HS-001 Low dose Administration

HS-001 High dose Administration

Outcomes

Primary Outcome Measures

Safety and Tolerability

Adverse events and safety in the 26 weeks after HS-001 CS transplantation

Secondary Outcome Measures

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

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

Myocardial blood flow in SPECT

Myocardial blood flow in the 26 weeks and 52 weeks after HS-001 CS transplantation

Myocardial viability in SPECT

Myocardial viability in the 26 weeks and 52 weeks after HS-001 CS transplantation

6-minute walk distance

6-minute walk distance in the 26 weeks and 52 weeks after HS-001 CS transplantation

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Kansas City Cardiomyopathy Questionnaire in the 26 weeks and 52 weeks after HS-001 CS transplantation

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

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

Full Information

NCT ID

NCT04945018

First Posted

June 22, 2021

Last Updated

November 17, 2022

Sponsor

Heartseed Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04945018

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 19, 2022 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Heartseed Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Ischemic Heart Disease

Keywords

Heart Failure, Ischemic Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HS-001 Low dose

Arm Type

Experimental

Arm Description

HS-001 Low dose Administration

Arm Title

HS-001 High dose

Arm Type

Experimental

Arm Description

HS-001 High dose Administration

Intervention Type

Biological

Intervention Name(s)

HS-001 CS

Intervention Description

Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension

Intervention Type

Device

Intervention Name(s)

HS-001-D needle, HS-001-D Adaptor

Intervention Description

Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors

Primary Outcome Measure Information:

Title

Safety and Tolerability

Description

Adverse events and safety in the 26 weeks after HS-001 CS transplantation

Time Frame

26 weeks post-transplant

Secondary Outcome Measure Information:

Title

Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography

Description

Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-001 CS transplantation

Time Frame