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

Help Therapeutics

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Heart Failure At NYHA Stage III or IV; Heart Failure

Treatments: Other: CABG/LVAD+Saline; Biological: low dose CABG+iPSC-CMs; Biological: High dose CABG/LVAD+iPSC-CMs

Study type: Interventional

Funder types: Industry

Identifiers

NCT06866600

SYF, WLS

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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:

  1. Definitive indication for LVAD implantation due to end-stage heart failure.
  2. Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection.
  3. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Control group

Sham Comparator group

Description:

CABG combined with saline or LVAD combined with saline

Treatment:

Other: CABG/LVAD+Saline

Low Dose Group

Experimental group

Description:

CABG combined with 0.5×10\^8 iPSC-CMs

Treatment:

Biological: low dose CABG+iPSC-CMs

High dose group

Experimental group

Description:

CABG combined with 1.5×10\^8 iPSC-CMs or LVAD combined with 1.5×10\^8 iPSC-CMs

Treatment:

Biological: High dose CABG/LVAD+iPSC-CMs