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Not yet recruiting NCT06866600

IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure

Phase I / Phase II Interventional Heart Failure Heart Failure At NYHA Stage III or IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low dose CABG+iPSC-CMs, High dose CABG/LVAD+iPSC-CMs, CABG/LVAD+Saline.
Who it may be relevant to
Registry conditions: Heart Failure, Heart Failure At NYHA Stage III or IV. Basic parameters: 35 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study on the Safety and Efficacy of Human IPSC-Derived Cardiomyocytes in the Treatment of End-Stage Heart Failure

Overview

This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.

Interventions

  • Biological low dose CABG+iPSC-CMs
    CABG+0.5×10\^8 iPSC-CMs
  • Biological High dose CABG/LVAD+iPSC-CMs
    CABG+1.5×10\^8 iPSC-CMs or LVAD+1.5×10\^8 iPSC-CMs
  • Other CABG/LVAD+Saline
    CABG/LVAD+Saline

Primary outcome measures

  • 6-minute walk test [Time frame: baseline, 1, 3, 6, 12 months post-operation]
  • Major Adverse Cardiovascular Events [Time frame: From enrollment to the end of study at 12 months]
  • Survival rate [Time frame: From enrollment to the end of study at 12 months]
Secondary outcome measures (6)
  • Left ventricular ejection fraction [Time frame: baseline, 1, 3, 6, 12 months post-operation]
  • Cardiac magnetic resonance detection index [Time frame: baseline, 1, 3, 6, 12 months post-operation]
  • BNP [Time frame: baseline, 1, 3, 6, 12 months post-operation]
  • SF-36 [Time frame: baseline, 1, 3, 6, 12 months post-operation]
  • KCCQ [Time frame: baseline, 1, 3, 6, 12 months post-operation]
  • Removal rate of LVAD [Time frame: From enrollment to the end of study at 12 months]

Eligibility criteria

Inclusion criteria

  • Male or female aged 35-75 years (inclusive) at the time of signing the informed consent form.
  • Capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form.
  • Diagnosed with end-stage heart failure.
  • Receiving optimized medical therapy for heart failure, with New York Heart Association (NYHA) functional class III-IV.
  • Echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall.
  • Cardiac magnetic resonance imaging (MRI) confirming left ventricular ejection fraction (LVEF) ≤35%.
  • Myocardial perfusion-metabolism imaging with radionuclide indicating infarcted myocardium in the left anterior descending (LAD) artery territory.
  • Meets criteria for coronary artery bypass grafting (CABG) under cardiopulmonary bypass during screening and requires CABG surgery.
  • For patients enrolled in the LVAD implantation group, the following additional criteria must be met:
  • Definitive indication for LVAD implantation due to end-stage heart failure.
  • Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection.
  • Absence of significant contraindications for LVAD surgery.

Exclusion criteria

  • History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
  • Severe valvular heart disease.
  • Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening.
  • Non-ischemic cardiomyopathy or acute viral myocarditis.
  • Acute cerebrovascular event within 1 month prior to screening.
  • History of malignancy within 5 years prior to screening.
  • Autoimmune disease or chronic use of immunosuppressive agents.
  • History of organ transplantation.
  • Planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure/resection).
  • Malignant ventricular arrhythmia.
  • Contraindications for CABG surgery.
  • Positive serology for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody.
  • Inability to undergo cardiac MRI or PET/CT imaging.
  • Contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen.
  • Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate/methylprednisolone, other corticosteroids, or basiliximab.
  • Participation in another clinical trial within 3 months prior to screening.
  • Pregnancy, lactation, or positive pregnancy test in female patients.
  • Any other condition deemed by the investigator to render the patient unsuitable for trial participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • HelpThera — Nanjing

Identifiers

NCT: NCT06866600 · SYF, WLS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗