HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery

Официальное название

A Phase I/IIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure

Обзор

This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery. Participants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.

Подробное описание

This is a Phase I/IIa, open-label, dose-escalation study of HiCM-188 in adult participants with advanced heart failure. HiCM-188 is an investigational cell therapy product consisting of allogeneic human iPSC-derived cardiomyocytes intended for intramyocardial administration.

Eligible participants will receive HiCM-188 during coronary artery bypass grafting (CABG) surgery. The study uses a 3+3 dose-escalation design to evaluate two dose levels of HiCM-188: 0.5 × 10\^8 cells and 1.5 × 10\^8 cells. The primary objective is to evaluate the safety and tolerability of intramyocardial injection of HiCM-188. Secondary objectives include evaluation of preliminary efficacy based on cardiac function, myocardial perfusion, exercise capacity, NYHA functional classification, quality of life, and major adverse cardiac events.

Participants will be monitored during the in-hospital period after CABG surgery and HiCM-188 administration, and then followed for up to 12 months after treatment.

Вмешательства

• Препарат HiCM-188 Cells
  HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.

Первичные конечные точки

• Incidence of Serious Adverse Events [Срок оценки: Up to 12 months post-transplant]

Вторичные конечные точки (9)

• Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI [Срок оценки: Baseline, 6 months, and 12 months]
• Change From Baseline in Left Ventricular End-Diastolic Volume by Cardiac MRI [Срок оценки: Baseline, 6 months, and 12 months]
• Change From Baseline in Left Ventricular End-Systolic Volume by Cardiac MRI [Срок оценки: Baseline, 6 months, and 12 months]
• Change From Baseline in Infarct Size by Cardiac MRI [Срок оценки: Baseline, 6 months, and 12 months]
• Change From Baseline in Myocardial Tissue Perfusion by PET/CT or SPECT [Срок оценки: Baseline, 6 months, and 12 months]
• Change From Baseline in 6-Minute Walk Distance [Срок оценки: Baseline, 6 months, and 12 months]
• Change From Baseline in New York Heart Association Functional Classification [Срок оценки: Baseline, 6 months, and 12 months]
• Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score [Срок оценки: Baseline, 6 months, and 12 months]
• Incidence of Major Adverse Cardiac Events [Срок оценки: Up to 12 months post-transplant]

Критерии участия

Критерии включения

• Able to sign informed consent and comply with the study protocol
• 18 to 75 years old at the time of signing informed consent
• Advanced heart failure patients with New York Heart Association (NYHA) class III to IVa despite receiving guideline-directed medical therapy (GDMT)
• Patients with an indication for coronary artery bypass grafting (CABG) per 2011 ACCF/AHA Guideline meeting a Class of Recommendation (COR) of Class I or Class IIa
• Minimum left ventricular wall thickness of ≥ 8 mm in the areas of injection, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
• Left ventricular ejection fraction (LVEF) of 20% to 45%, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
• Other criteria apply. Please contact the investigator for more information.

Критерии исключения

• Viral myocarditis
• Amyloidosis
• Pericardial disorders or pericarditis
• Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area
• Primary significant organic valvular heart disease, with specified dimensions
• Untreated congenital heart disease
• Complete atrioventricular (AV) conduction block
• History of left ventricular assist device surgery
• Other criteria apply. Please contact the investigator for more information.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Texas Heart Institute at Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT07646210 · HICM188H1101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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