Clinical trial NCT06866600: IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure
Official title: Study on the Safety and Efficacy of Human IPSC-Derived Cardiomyocytes in the Treatment of End-Stage Heart Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Heart Failure At NYHA Stage III or IV
Keywords: LVAD
CABG
iPSC-CMs
Lead sponsor: Help Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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:

  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.

Primary outcomes:
measure: 6-minute walk test
timeFrame: baseline, 1, 3, 6, 12 months post-operation
measure: Major Adverse Cardiovascular Events
timeFrame: From enrollment to the end of study at 12 months
measure: Survival rate
timeFrame: From enrollment to the end of study at 12 months
Secondary outcomes:
measure: Left ventricular ejection fraction
timeFrame: baseline, 1, 3, 6, 12 months post-operation
measure: Cardiac magnetic resonance detection index
timeFrame: baseline, 1, 3, 6, 12 months post-operation
measure: BNP
timeFrame: baseline, 1, 3, 6, 12 months post-operation
measure: SF-36
timeFrame: baseline, 1, 3, 6, 12 months post-operation
measure: KCCQ
timeFrame: baseline, 1, 3, 6, 12 months post-operation
measure: Removal rate of LVAD
timeFrame: From enrollment to the end of study at 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: HelpThera
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)
name: Yongfeng Shao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)
name: Liansheng Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: