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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04945018
Recruitment Status : Not yet recruiting
First Posted : June 30, 2021
Last Update Posted : March 16, 2022
Sponsor:
Information provided by (Responsible Party):
Heartseed Inc.

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.

Condition or disease Intervention/treatment Phase
Heart Failure Ischemic Heart Disease Biological: HS-001 CS Device: HS-001-D needle, HS-001-D Adaptor Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 19, 2022
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HS-001 Low dose
HS-001 Low dose Administration
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

Experimental: HS-001 High dose
HS-001 High dose Administration
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




Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 26 weeks post-transplant ]
    Adverse events and safety in the 26 weeks after HS-001 CS transplantation


Secondary Outcome Measures :
  1. Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography [ Time Frame: 26 weeks and 52 weeks post-transplant ]
    Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-001 CS transplantation

  2. Myocardial wall motion evaluation in Echocardiography [ Time Frame: 26 weeks and 52 weeks post-transplant ]
    Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks after HS-001 CS transplantation

  3. Myocardial blood flow in SPECT [ Time Frame: 26 weeks and 52 weeks post-transplant ]
    Myocardial blood flow in the 26 weeks and 52 weeks after HS-001 CS transplantation

  4. Myocardial viability in SPECT [ Time Frame: 26 weeks and 52 weeks post-transplant ]
    Myocardial viability in the 26 weeks and 52 weeks after HS-001 CS transplantation

  5. 6-minute walk distance [ Time Frame: 26 weeks and 52 weeks post-transplant ]
    6-minute walk distance in the 26 weeks and 52 weeks after HS-001 CS transplantation

  6. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 26 weeks and 52 weeks post-transplant ]
    Kansas City Cardiomyopathy Questionnaire in the 26 weeks and 52 weeks after HS-001 CS transplantation

  7. 5-level EQ-5D version (EQ-5D-5L) [ Time Frame: 26 weeks and 52 weeks post-transplant ]
    5-level EQ-5D version (EQ-5D-5L) in the 26 weeks and 52 weeks after HS-001 CS transplantation

  8. N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) [ Time Frame: 26 weeks and 52 weeks post-transplant ]
    N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in the 26 weeks and 52 weeks after HS-001 CS transplantation



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04945018


Contacts
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Contact: Heartseed Inc. 0363801068 contact@heartseed.jp

Locations
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Japan
St. Marianna University Hospital
Kawasaki, 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
Sponsors and Collaborators
Heartseed Inc.
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Responsible Party: Heartseed Inc.
ClinicalTrials.gov Identifier: NCT04945018    
Other Study ID Numbers: HS-001-01
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heartseed Inc.:
Heart Failure
Ischemic Heart Disease
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases