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

Heartseed

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Ischemic Heart Disease; Heart Failure

Treatments: Device: HS-001-D needle, HS-001-D Adaptor; Biological: HS-001 CS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04945018

HS-001-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

HS-001 Low dose

Experimental group

Description:

HS-001 Low dose Administration

Treatment:

Biological: HS-001 CS

Device: HS-001-D needle, HS-001-D Adaptor

HS-001 High dose

Experimental group

Description:

HS-001 High dose Administration

Treatment:

Biological: HS-001 CS

Device: HS-001-D needle, HS-001-D Adaptor