An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Autologous Adipose-Derived Stromal Cells Implantation by a Catheter Delivery System and/or Intravenously In Patients During the Acute Recovery Phase of ST-Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Cardiac Improvement
研究概览
简要总结
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?
详细描述
The primary objectives of this study are to evaluate in patients recovering from acute myocardial infarction (< 8 days after the index infarction) both the safety profile of intramyocardial ASCs and the preliminary efficacy of ASCs therapy.
This will be an open-label, non-randomized patient sponsored multi-center study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The injection catheter will be used for delivery of the ASCs therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females between Age 18 and 80 years.
- •Defined acute myocardial infarction <8 days from screening
- •Left ventricular ejection fraction at screening of ≤ 50%, with 2 or more contiguous areas of severe wall motion abnormality on resting echocardiography.
- •Patients must have a minimum myocardial wall thickness of 5mm
- •Need or feasibility for re-vascularization has been ruled out by coronary angiogram or noninvasive stress testing.
- •Up to date on all age and gender appropriate cancer screening per American Cancer Society
排除标准
- •Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- •Life expectancy < 6 months due to concomitant illnesses.
- •NYHA CHF Class 4
- •Severe valvular or other non-ischemic myocardial disease.
- •Mechanical complications of the index acute myocardial infarction including but not limited to rupture of the mitral valve with resultant development of mitral regurgitation, rupture of the left ventricular free wall and rupture of the interventricular septum.
- •Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. If the panel includes antibodies to the HBV-cAg and HBV-sAg, then an expert will be consulted as to patient eligibility based on the patient's infectious status
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Systolic blood pressure (supine) ≤90 mmHg;
- •Resting heart rate > 100 bpm;
- •Active clinical infection within one week of enrollment.
- •Cerebrovascular accident within 6 months prior to study entry
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- •Unwilling and/or not able to give written informed consent.
结局指标
主要结局
Cardiac Improvement
时间窗: 6 months
Autologous ASCs therapy will be considered effective for post-myocardial infarction patients if there is an improvement in: * Absolute LVEF * Changes in LVEF from baseline to 6 months * MI size * Regional wall thickness and thickening in all segments * LV-end systolic volume (LV-ESV) * LV-end diastolic volume (LV-EDV) * Change in perfusion defect after revascularization to six months as measured by: * Echocardiography * Scintigraphy
次要结局
- Primary Safety Objective(6 months)