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Heart FailurePhase 1/2NCT05223894

Treating Heart Failure With hiPSC-CMs

A Phase 1/2 study testing hiPSC-CM therapy in people with Heart Failure, run by HELP Therapeutics Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Heart failure has a high morbidity and mortality because the heart is one of the least regenerative organs in the human body. Drug treatments for heart failure manage symptoms but do not restore lost myocytes. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Heart Failure
What is being tested?
hiPSC-CM therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteChina
Study dates
30 Jun 2022to 30 Dec 2025
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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 35-75 (including 35 and 75).
  • Have signed the Informed Consent Form (ICF).
  • Patients have chronic left ventricular dysfunction.
  • Patients have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
  • Patients have indications for Coronary Artery Bypass Grafting.
  • 20% ≤ LVEF ≤ 40% as determined by echocardiogram (data collected up to 3 months prior to inclusion evaluation are valid; data collected within 1 month since a myocardial infarction are invalid).
  • Weakening or absence of segmental regional wall motion as determined by standard imaging.

Who cannot join

  • PRA ≥ 20% or DSA-positive.
  • Patient received ICD transplantation, CRT or similar treatment.
  • Patients with valvular heart disease or received heart valvular disease
  • Patients received treatment of percutaneous transluminal coronary intervention (PCI)
  • Patients with atrial fibrillation
  • Patients previously suffered sustained ventricular tachycardia or sudden cardiac death.
Show all 21Show fewer
  • Baseline glomerular filtration rate <30ml/min/1.73m2.
  • Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
  • Hematological abnormality: A hematocrit <25% as determined by HCT, white blood cell<2500/ul or platelet values <100000/ul without another explanation.
  • Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy.
  • Coagulopathy (INR>1.3) not due to a reversible cause.
  • Contra-indication to performance of a MRI scan.
  • Recipients of organ transplant.
  • Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years).
  • Non-cardiac condition that limits lifespan <1 year.
  • On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNF-α antagonist.
  • Patients allergy to or cannot use immunosuppressant.
  • Serum positive for HIV, HBV, HCV, TP.
  • Currently enrolled other investigational therapeutic or device study.
  • Patients who are pregnant or breast feeding.
  • Other conditions that researchers consider not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

Gang Yang, MD,PhD contact

+86-18601406982

yanggang@helpsci.com.cn

China1 site, 1 recruiting

  • Shanghai east Hospital

    Shanghai, Shanghai Municipality

    Zhongmin Liu

    Recruiting

Other trials in China

About this study

Official title: Epicardial Injection of Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure

Heart failure has a high morbidity and mortality because the heart is one of the least regenerative organs in the human body. Drug treatments for heart failure manage symptoms but do not restore lost myocytes. Cellular replacement therapy is a potential approach to repair damaged myocardial tissue, restore cardiac function, which has become a new strategy for the treatment of heart failure. The purpose of this study is to assess the safety and efficacy of intramyocardial delivery of cardiomyocytes at the time of coronary artery bypass grafting in patients with chronic heart failure.

Read the detailed description

Patients with heart failure will be treated with allogenic human pluripotent stem cell-derived cardiomyocytes ( hPSC-CM ) from healthy donors. The cells will be injected directly into the myocardium at time of coronary artery bypass grafting. Patients will be assessed at 1, 3, 6 and 12 months after cell transplantation for safety and efficacy.

Conditions
Heart Failure
Being tested
hiPSC-CM therapy, Control
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hiPSC-CM therapyBiological

    Injection of allogenic human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) during coronary artery bypass grafting surgery. 100 million hPSC-CMs in 2.5-5 mL medium suspension will be injected into the myocardium.

  • ControlOther

    Coronary artery bypass grafting surgery only.

Study groups in NCT05223894
Study groupRoleWhat they receive
hiPSC-CM therapyExperimentalInjection of allogenic human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) during coronary artery bypass grafting surgery. 100 million hPSC-CMs in 2.5-5 mL medium suspension will be injected into the myocardium.
Receives: Biological: hiPSC-CM therapy
ControlSham comparatorCoronary artery bypass grafting surgery only.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of serious adverse events(SAEs) within 1 month post-CABG surgery.

    Incidence of serious adverse events(SAEs) within 1 month post-CABG surgery. These include death, fatal myocardial infarction, stroke, cardiac tamponade, cardiac perforation, hemodynamic ventricular arrhythmias (duration > 15s), and new allogeneic human neoplasms.

    Measured: 1 Month Post-operation

Secondary outcomes (20)

  1. Size of infracted myocardium assessed by MRI

    Size of infracted myocardium;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  2. Left Ventricular systolic performance as assessed by MRI

    left ventricular side wall thickness at diastolic; interventricular septum thickness;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  3. Left ventricular ejection fraction assessed by MRI

    left ventricular ejection fraction;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  4. Overall Left Ventricular systolic performance as assessed by MRI

    left ventricular end-systolic volume and end-diastolic volume; stroke volume;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  5. Cardiac output assessed by MRI

    cardiac output;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  6. Myocardium density assessed by MRI

    myocardium density;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  7. Left ventricular mass assessed by MRI

    left ventricular mass at diastolic;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  8. Overall Left Ventricular systolic performance as assessed by Echocardiogram

    Interventricular septum thickness at diastolic; left ventricular posterior wall thickness at diastolic;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  9. Left Ventricular systolic performance as assessed by Echocardiogram

    left ventricular end-systolic diameter and end-diastolic diameter; left atrial diameter;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  10. Left ventricular ejection fraction assessed by Echocardiogram

    left ventricular ejection fraction;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  11. Mitral flow pattern (E/A) assessed by Echocardiogram

    mitral flow pattern (E/A) ;

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  12. Overall Left Ventricular systolic performance as assessed by PET/ECT Scan

    Myocardium perfusion

    Measured: Baseline, 6 and 12 Months Post-operation

  13. Functional status by 6 minute walk test

    Evaluate Functional Capacity via the Six Minute Walk Test

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  14. Functional status by New York Heart Association (NYHA) Classification

    Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination.

    It classifies patients in one of four categories based on their limitations during physical activity; Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

    Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

    Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.

    Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  15. Minnesota Living With Heart Failure Questionnaire (MLHFQ)

    Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF). The Maximum possible scores being 105 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life.

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  16. Incidence of Serious Adverse Events (SAE)

    SAE justified (all undesirable or unintended diseases or laboratory and imaging disorders and symptoms that occur in subjects after CABG surgery and 12 months postoperative follow-up, or until the subject withdrawals from the study. AE grading will be based on Common Terminology Criteria for Adverse Events (CTCAE) V5.0.)

    Measured: Baseline, 1~12Months Post-operation

  17. Incidence of severe arrhythmia

    Clinically significant arrhythmias will be recorded by Electrocardiogram monitoring

    Measured: First month post-operatively

  18. Changes in penal reactive antibodies (PRA)

    Changes in penal reactive antibodies (PRA) as assessed via blooddraw

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  19. Changes in donor specific antibodies (DSA)

    Changes in donor specific antibodies (DSA) as assessed via blooddraw

    Measured: Baseline, 1, 3, 6 and 12 Months Post-operation

  20. Changes in cytokines

    Change in NT-proBNP as assessed via blooddraw

    Measured: Baseline,1, 3, 6 and 12 Months Post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start30 Jun 2022
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05223894
Sponsor's protocol ID
ZMLiu
Status last verified
Nov 2023
First submitted
22 Dec 2021
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing hiPSC-CM therapy in people with Heart Failure, run by HELP Therapeutics Co., Ltd. at 1 site in China.

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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gang Yang, MD,PhD (+86-18601406982, yanggang@helpsci.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of serious adverse events(SAEs) within 1 month post-CABG surgery. (time frame: 1 Month Post-operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05223894.

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 Nov 2023.

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