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Идёт набор NCT07496372

A Pivotal Clinical Trial of Human Induced Pluripotent Stem Cell-derived Cardiomyocytes Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)

Фаза III С лечением Heart Failure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: HiCM-188 therapy, CABG surgery.
Кому может быть актуально
Состояния в реестре: Heart Failure. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Pivotal Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)

Обзор

The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)

Подробное описание

REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppressive therapy. Efficacy and safety were assessed 12 months post-treatment.

Вмешательства

  • Биопрепарат HiCM-188 therapy
    Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
  • Процедура CABG surgery
    Conventional coronary artery bypass grafting (CABG) surgery

Первичные конечные точки

  • 6-minute walk distance (6MWD) [Срок оценки: 12 months after surgery]
Вторичные конечные точки (12)
  • All-cause mortality and cardiovascular mortality [Срок оценки: 12 months after surgery]
  • 6MWD [Срок оценки: 6 months after surgery]
  • Change from baseline in the NYHA classification [Срок оценки: 12 months after surgery]
  • Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure) [Срок оценки: 12 months after surgery]
  • Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [Срок оценки: 12 months after surgery]
  • Change from baseline in the SF-36 questionnaire [Срок оценки: 12 months after surgery]
  • Myocardial blood flow as assessed by SPECT [Срок оценки: 12 months after surgery]
  • Myocardial viability as assessed by SPECT [Срок оценки: 12 months after surgery]
  • Left ventricular ejection fraction as assessed by MRI [Срок оценки: 12 months after surgery]
  • Cardiac Volumes as assessed by MRI [Срок оценки: 12 months after surgery]
  • Scar size as assessed by MRI [Срок оценки: 12 months after surgery]
  • Change from baseline in NT-proBNP level [Срок оценки: 12 months after surgery]

Критерии участия

Критерии включения

  • Aged 18 to 75 years, regardless of gender;
  • Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
  • LVEF ≤ 35% as measured by cardiac MRI;
  • Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
  • Voluntary participation and signing of the informed consent form.

Критерии исключения

Patients considered for this trial must not meet any of the following criteria:

  • Acute viral myocarditis;
  • Acute phase of myocardial infarction (≤ 3 months);
  • Cardiac amyloidosis;
  • Pericarditis;
  • Expected to undergo heart transplantation;
  • Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
  • Suffering from autoimmune diseases;
  • Estimated glomerular filtration rate (eGFR) < 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 100 U/L;
  • Presence of any untreated precancerous lesions or those requiring active monitoring;
  • Occurrence of malignant tumors within 5 years prior to screening;
  • Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation);
  • Having contraindications to the use of immunosuppressants;
  • Having contraindications to MRI;
  • Having contraindications to CABG surgery;
  • Females who are pregnant, lactating, or have a positive blood pregnancy test;
  • Plans to conceive within one year;
  • Having systemic diseases that are not effectively controlled;
  • Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.

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
  • TEDA International Cardiovascular Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07496372 · Liu XC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗