NCT01670981已完成2 期
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of Transendocardial Injection of Ixmyelocel-T in Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM).
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 72
- 主要终点
- Average number of clinical events over 12 months post-treatment.
研究概览
简要总结
This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.
详细描述
The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure, over the 12 months following administration of investigational product (IP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant, non-lactating females;
- •Age 30 to 86 years of age;
- •Diagnosis of ischemic dilated cardiomyopathy;
- •LVEF ≤ 35% by echocardiogram;
- •Symptomatic heart failure in NYHA functional class III or IV;
- •Subject is not a candidate for reasonable revascularization procedures that will produce clinical improvement;
- •Subject is receiving appropriate clinical standard of care heart failure therapy, as tolerated and as dictated by a subject's current medical condition, for at least 30 days prior to screening;
- •Must have an automatic implantable cardioverter defibrillator (AICD);
- •Worsening heart failure hospitalization or equivalent within 6 months prior to screening, hospitalization equivalent defined as an unplanned outpatient/emergency department visit for treatment of acute decompensated heart failure; or have an N-terminal prohormone B-type natriuretic peptide (NT-proBNP) ≥2000 pg/mL or BNP ≥400 pg/mL within 30 days of screening (including screening); or have a 6-minute walk test (6MWT) distance of ≤400 meters at screening;
- •Life expectancy of at least 12 months in the opinion of the Investigator;
- •LV wall thickness ≥ 7mm (by echocardiogram) at anticipated target injection area;
- •Hemodynamic stability without IV vasopressors or support devices;
- •Given medical history and concurrent medication, subject is an acceptable candidate for bone marrow aspiration and cardiac catheterization and transendocardial injection procedures in the opinion of the Investigator;
- •Willing and able to comply scheduled visits and tolerate study procedures.
- •Voluntarily provide a personally-signed and dated informed consent.
排除标准
- •Disease-specific:
- •Severe primary valvular heart disease including, but not limited to, aortic valve stenosis and insufficiency;
- •VAD implantation, heart transplantation, cardiomyoplasty, left ventricular reduction surgery, or cardiac shunt implantation;
- •Planned heart failure-related device interventions (e.g., VAD implantation, initial cardiac resynchronization therapy) or planned cardiac procedures (e.g., heart transplant, cardiomyoplasty, valvular repair);
- •Current arrhythmias that would prohibit accurate NOGA® electromechanical mapping and NOGA®-guided injections;
- •LV thrombus (as documented on echocardiography or LV angiography);
- •Myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening;
- •Percutaneous coronary intervention, valvuloplasty, cardiac surgery, and other major cardiac procedure within 30 days prior to screening;
- •In the opinion of the Investigator, the subject's left ventricular wall is unsuitable for transendocardial injections (due to thickness or other reasons).
- •Medical History:
- •Stroke or transient ischemic attack (TIA) within 3 months of screening;
- •Hemoglobin A1c (HbA1c) ≥ 9% at screening;
- •Diabetic subjects with uncontrolled or untreated proliferative retinopathy as determined by dilated eye exam administered by a qualified eye care professional as per American Diabetes Association guidelines;
- •Blood clotting disorder not caused by medication (e.g., thrombophilia);
- •Active malignancy (non-basal cell) requiring surgery, chemotherapy, and/or radiation in the past 12 months;
- •Drug or alcohol abuse that would interfere with the subject's compliance with study procedures;
- •Allergies to any equine, porcine, or bovine products;
- •Body mass index (BMI) ≥ 40 kg/m2 at screening;
- •Established chronic kidney disease (CKD) requiring dialysis (Stage 5); estimated creatinine clearance < 15 mL/min at screening;
- •Subject has allergy or is unable to tolerate cardiac imaging contrast agents; also the inability to get a good quality echocardiogram image at screening (as determined by the imaging core lab).
- •Laboratory Parameters:
- •Abnormal laboratory values (performed at central lab) at screening:
- •Platelets < 50,000 μL;
- •Hemoglobin < 9.0 g/dL;
- •Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 3 times the upper limit of normal (ULN);
- •Human immunodeficiency virus 1 (HIV 1), HIV 2, or syphilis positive (rapid plasma reagin [RPR]);
- •Active hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies;
- •NOTE: Additional lab tests may be performed per local requirements including but not limited to: hepatitis B core antibody, human T lymphotropic virus I/II.
- •Exclusionary Procedures, Devices, or Medication:
- •Subjects receiving anti-angiogenic drugs (e.g., anti-vascular endothelial growth factor [VEGF]);
- •Chronic exposure to cytotoxic therapy for oncologic or chronic non-oncologic reasons in the prior 3 months or expected requirement over the course of the study;
- •Concurrent participation in another interventional clinical trial or receiving experimental intervention within 30 days of screening or having previously been exposed to Aastrom's ixmyelocel T product or previously received allogeneic cell therapy, autologous cell therapy cultured with animal proteins.
- •In the opinion of the Investigator, the subject is unsuitable for cellular therapy or has a food/drug allergy, surgical or medical condition, clinically significant psychiatric disorders, poor nutritional status, or lab abnormality requiring further medical evaluation that may interfere with the investigational product, interfere with the study results' interpretation, interfere with the subject's ability to complete the study or compromise the subject's safety.
结局指标
主要结局
Average number of clinical events over 12 months post-treatment.
时间窗: 12 Months
The primary endpoint will assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average number of events per patient over 12 months post-treatment in each treatment arm (total number events in each arm/total number of patients in each arm). The events include: all-cause deaths, cardiovascular hospitalizations, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure. The clinical events used in this endpoint will be adjudicated by an independent clinical endpoint committee who are blinded to treatment.
次要结局
- Percent of patients with adverse events.(12 Months)
- Change from baseline to 12 months post-treatment in 6-minute walk test.(12 Months)
- Change from baseline to 12 months post-treatment in NYHA Classification.(12 Months)
- The win ratio of the hierarchical occurrence of all-cause deaths/left ventricular assist device (LVAD) implant/heart transplant, cardiovascular hospitalizations, and unplanned outpatient and ED interventions to treat ADHF(12 Months)
- Change from baseline to 12 months post-treatment in left ventricular function as evaluated by echocardiography.(12 Months)
- Change from baseline to 12 months post-treatment in quality of life.(12 Months)
- Percent of patients with major adverse cardiac events (MACE).(12 Months)
研究者
研究点 (72)
Loading locations...
相似试验
已完成
3 期
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)Critical Limb IschemiaNCT01483898Vericel Corporation41
已完成
2 期
Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung CancerLocally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)NCT02179671AstraZeneca32
Unknown
2 期
A Study To Evaluate the Safety, Tolerance, Pharmacokinetics/Pharmacodynamics and Efficacy of SYHA1402 Tablets For the Treatment of Patients With Diabetic Peripheral Neuropathy in ChinaDistal Symmetric Polyneuropathy (DSPN)NCT05116111CSPC ZhongQi Pharmaceutical Technology Co., Ltd.135
进行中（未招募）
2 期
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)Alzheimers DiseaseAlzheimers Disease, FamilialDementiaNCT05269394Washington University School of Medicine197
已完成
1 期
Tolerability, Safety, and Immunogenicity of Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).Hand, Foot, and Mouth Disease (HFMD)HerpanginaNCT06754384Sinovac Biotech Co., Ltd552