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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 6-minute walk test [Срок оценки: baseline, 1, 3, 6, 12 months post-operation]
• Major Adverse Cardiovascular Events [Срок оценки: From enrollment to the end of study at 12 months]
• Survival rate [Срок оценки: From enrollment to the end of study at 12 months]

Вторичные конечные точки (6)

• Left ventricular ejection fraction [Срок оценки: baseline, 1, 3, 6, 12 months post-operation]
• Cardiac magnetic resonance detection index [Срок оценки: baseline, 1, 3, 6, 12 months post-operation]
• BNP [Срок оценки: baseline, 1, 3, 6, 12 months post-operation]
• SF-36 [Срок оценки: baseline, 1, 3, 6, 12 months post-operation]
• KCCQ [Срок оценки: baseline, 1, 3, 6, 12 months post-operation]
• Removal rate of LVAD [Срок оценки: From enrollment to the end of study at 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• HelpThera — Нанкин

Идентификаторы

NCT: NCT06866600 · SYF, WLS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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