CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction

Официальное название

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial

Обзор

Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.

Подробное описание

Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure and are well supported by recent meta analyses of early clinical data sets. Concentrated autologous bone marrow mononuclear cells (ABM MNC) are the subject of the current study as they are supported by more clinical data than any other cell type described, and contain all of the potentially therapeutic cell factors from studies of selected cells. Study results demonstrate ABM MNC to be safe, and, when delivered intramyocardially as intended in the current study, results consistently support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization. The Treatment Group undergoes left ventricular catheterization and is treated with ABM MNC using the CardiAMP cell therapy system. The Control Group has a Control procedure consisting of left ventricular diagnostic catheterization but no introduction of the Helix transendocardial delivery catheter and no administration of ABM MNC.

Вмешательства

• Устройство Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
  the ABM MNC is obtained from the study patient via bone marrow aspiration in the hip and processed and delivered using the CardiAMP cell therapy system during the cardiac catheterization.

Первичные конечные точки

• Primary Efficacy Endpoint [Срок оценки: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months]

Вторичные конечные точки (7)

• First Secondary Endpoint [Срок оценки: Baseline through study completion, maximum of two years]
• Second Secondary Endpoint [Срок оценки: Baseline through study completion, maximum of two years]
• Third Secondary Endpoint [Срок оценки: Baseline through study completion, maximum of two years]
• Fourth Secondary Endpoint [Срок оценки: Baseline to 12 months, 24 months]
• Fifth Secondary Endpoint [Срок оценки: Baseline to 12 months, 24 months]
• Sixth Secondary Endpoint [Срок оценки: Baseline to 12 months, 24 months]
• Seventh Secondary Endpoint [Срок оценки: Baseline through study completion, maximum of two years]

Критерии участия

Критерии включения

• New York Heart Association (NYHA) Class II or III
• Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
• Left ventricular ejection fraction >20% and <40%
• On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
• NTproBNP level of >500 pg/ml
• Autologous cell analysis score consistent with study selection assessment

Критерии исключения

• Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Morton Plant Hospital - BayCare — Clearwater
• Emory University — Atlanta
• Henry Ford Hospital — Detroit
• Cleveland Clinic — Cleveland
• University of Wisconsin-Division of Cardiovascular Medicine — Madison

Идентификаторы

NCT: NCT06258447 · 05804 (CLIN)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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