Starting soon
Phase 1/2
IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure
Condition(s) studied
Heart FailureHeart Failure At NYHA Stage III or IV
Investigational drug(s) / intervention(s)
low dose CABG+iPSC-CMsHigh dose CABG/LVAD+iPSC-CMsCABG/LVAD+Saline
low dose CABG+iPSC-CMs: CABG+0.5×10\^8 iPSC-CMs
High dose CABG/LVAD+iPSC-CMs: CABG+1.5×10\^8 iPSC-CMs or LVAD+1.5×10\^8 iPSC-CMs
CABG/LVAD+Saline: CABG/LVAD+Saline
Study 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
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 outcome measure(s)
- 6-minute walk test — baseline, 1, 3, 6, 12 months post-operation
- Major Adverse Cardiovascular Events — From enrollment to the end of study at 12 months
The composite endpoint events occurring during the prescribed postoperative follow-up period included cardiac death, non-fatal myocardial infarction, non-fatal stroke, and emergency target vessel revascularization (e.g., PCI or CABG), which was expressed as the percentage of subjects experiencing at least one of these events (%).
- Survival rate — From enrollment to the end of study at 12 months
Trial sites (1)
| Facility | City | Region | Status |
| HelpThera |
Nanjing |
Jiangsu |
|
More HELP Therapeutics Co., Ltd. trials in China
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