Heart FailurePhase 1/2LAPiSNCT04945018
A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)
A Phase 1/2 study testing HS-001 CS and HS-001-D needle, HS-001-D Adaptor in people with Heart Failure and Ischemic Heart Disease, run by Heartseed Inc. at 8 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure, Ischemic Heart Disease
- What is being tested?
- HS-001 CS and HS-001-D needle, HS-001-D Adaptor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesJapan
- Study dates
- 19 Apr 2022to 31 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
St. Marianna University Hospital
Kawasaki
Saitama Medical University International Medical Center
Saitama
Juntendo University Hospital
Tokyo
Nihon University Itabashi Hospital
Tokyo
The University of Tokyo Hospital
Tokyo
Tokyo Medical and Dental University Medical Hospital
Tokyo
Tokyo Metropolitan Geriatric Medical Center
Tokyo
Tokyo Women's Medical University
Tokyo
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Ischemic Heart Disease
- Being tested
- HS-001 CS, HS-001-D needle, HS-001-D Adaptor
- Keywords
- Heart Failure, Ischemic Heart Disease
- Medical subject headings
- Heart Failure, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-001 CSBiological
Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension
HS-001-D needle, HS-001-D AdaptorDevice
Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors
| Study group | Role | What they receive |
|---|---|---|
| HS-001 Low dose | Experimental | HS-001 Low dose Administration Receives: Biological: HS-001 CS; Device: HS-001-D needle, HS-001-D Adaptor |
| HS-001 High dose | Experimental | HS-001 High dose Administration Receives: Biological: HS-001 CS; Device: HS-001-D needle, HS-001-D Adaptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Adverse events and safety in the 26 weeks after HS-001 CS transplantation
Measured: 26 weeks post-transplant
Secondary outcomes (8)
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
Measured: 26 weeks and 52 weeks post-transplant
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
Measured: 26 weeks and 52 weeks post-transplant
Myocardial blood flow in SPECT
Myocardial blood flow in the 26 weeks and 52 weeks after HS-001 CS transplantation
Measured: 26 weeks and 52 weeks post-transplant
Myocardial viability in SPECT
Myocardial viability in the 26 weeks and 52 weeks after HS-001 CS transplantation
Measured: 26 weeks and 52 weeks post-transplant
6-minute walk distance
6-minute walk distance in the 26 weeks and 52 weeks after HS-001 CS transplantation
Measured: 26 weeks and 52 weeks post-transplant
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Kansas City Cardiomyopathy Questionnaire in the 26 weeks and 52 weeks after HS-001 CS transplantation
Measured: 26 weeks and 52 weeks post-transplant
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
Measured: 26 weeks and 52 weeks post-transplant
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
Measured: 26 weeks and 52 weeks post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start19 Apr 2022
- Primary completion31 Jul 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartseed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945018
- Sponsor's protocol ID
- HS-001-01
- Acronym
- LAPiS
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04945018
- Acronym / sponsor ID
- LAPiS / HS-001-01
- Conditions
- Heart Failure, Ischemic Heart Disease
- Keywords
- Heart Failure, Ischemic Heart Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Heartseed Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-001 Low dose | Experimental | Biological: HS-001 CS, Device: HS-001-D needle, HS-001-D AdaptorHS-001 Low dose Administration |
| HS-001 High dose | Experimental | Biological: HS-001 CS, Device: HS-001-D needle, HS-001-D AdaptorHS-001 High dose Administration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-001 CSHuman (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension | Biological | HS-001 High dose, HS-001 Low dose |
| HS-001-D needle, HS-001-D AdaptorCardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors | Device | HS-001 High dose, HS-001 Low dose |
Primary outcome
Safety and Tolerability
Time frame: 26 weeks post-transplant
Adverse events and safety in the 26 weeks after HS-001 CS transplantation
8 secondary outcomes
Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography
Time frame: 26 weeks and 52 weeks post-transplant
Myocardial wall motion evaluation in Echocardiography
Time frame: 26 weeks and 52 weeks post-transplant
Myocardial blood flow in SPECT
Time frame: 26 weeks and 52 weeks post-transplant
Myocardial viability in SPECT
Time frame: 26 weeks and 52 weeks post-transplant
6-minute walk distance
Time frame: 26 weeks and 52 weeks post-transplant
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 26 weeks and 52 weeks post-transplant
5-level EQ-5D version (EQ-5D-5L)
Time frame: 26 weeks and 52 weeks post-transplant
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Time frame: 26 weeks and 52 weeks post-transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HS-001 CS and HS-001-D needle, HS-001-D Adaptor in people with Heart Failure and Ischemic Heart Disease, run by Heartseed Inc. at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 26 weeks post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.