Rapid Delivery of Autologous Bone Marrow Derived Stem Cells in Acute Myocardial Infarction Patients. (AMIRST)
Intracoronary Infusion of Concentrated Autologous Bone Marrow Mononuclear Cells in Acute Myocardial Infarction Patients Utilizing a Novel Point-of-Care Device for Rapid-Delivery of Stem Cells (AMIRST)
The primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac dysfunction following AMI.
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent placebo control patient group meeting eligibility but not receiving autologous bone marrow derived stem cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function.
研究概览
详细说明
Emerging evidence indicate that progenitor stem cells derived from bone marrow can be used to improve cardiac function in acute myocardial infarction patients. There is a great potential for stem cell therapy, using a variety of cell precursors to contribute to new blood vessel formation and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies. Across the globe AMI is the leading cause of morbidity and mortality. This cannot be prevented by optimal standard therapies i.e. balloon or stent dilation of the infarct vessels.
The study is a double blind, placebo controlled, randomized, multicenter trial. Male or female patients between 18-75 years with first incidence of Acute Myocardial Infarction(AMI) and LVEF less than or equal to 40% are included in the study. Patients who have undergone successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow are eligible to take part in the study.
A total of 30 subjects will be recruited and randomly assigned to receive concentrated BMMNC or placebo. All patients will undergo bone marrow aspiration within 3-10 days from the index event(infarction). Bone Marrow(BM) will be processed utilizing point of care technology. Following cell processing, the concentrated BMMNC or placebo control is infused directly into the infarct related artery using the stop flow method. Clinical follow up for all the subjects at 1,30, 60, 90, 180 and 360 days will be performed from the day of the procedure, with primary and secondary end points evaluated for both study arms.
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Kenneth Harris, MS
- 电话号码：13234207766
- 邮箱：ken.harris@totipotentrx.com
研究联系人备份
- 姓名：Venkatesh Ponemone, PhD
- 电话号码：911244976860
- 邮箱：ponemone@totipotentrx.com
学习地点
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Hyderabad、印度、500034
- CARE Hospitals, Banjara Hills
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接触：
- Sreenivas A Kumar
- 电话号码：040-30418126
- 邮箱：arramraj@yahoo.com
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首席研究员：
- Sreenivas A Kumar, MD, DM, FACC
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副研究员：
- Venkatesh Ponemone, PhD
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New Delhi、印度、110025
- Fortis Escorts Heart Institute and Research Centre
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副研究员：
- Venkatesh Ponemone, PhD
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接触：
- Ashok Seth, FRCS, FSCAI
- 电话号码：911147134232
- 邮箱：ashok.seth@fortishealthcare.com
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接触：
- Vinay Sanghi, MD
- 电话号码：911147135000
- 邮箱：vinay.sanghi@fortishealthcare.com
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首席研究员：
- Ashok Seth, FRCS, FSCAI
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副研究员：
- Upendra Kaul, MD, DM, FACC
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副研究员：
- Vishal Rastogi, MD, DM
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副研究员：
- Vinay Sanghi, FACP,FACC
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副研究员：
- Mona Bhatia, MD
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New Delhi、印度、110070
- Fortis Flt. Lt. Rajan Dhall Hospital
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副研究员：
- Venkatesh Ponemone, PhD
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副研究员：
- Mona Bhatia, MD
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接触：
- Upendra Kaul, MD
- 电话号码：911147135000
- 邮箱：upendra.kaul@fortishealthcare.com
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接触：
- Tapan Ghose, MD
- 电话号码：911147134232
- 邮箱：tapan.ghose@fortishealthcare.com
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首席研究员：
- Upendra Kaul, MD, DM, FACC
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副研究员：
- Tapan Ghose, MD
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副研究员：
- Ripen Gupta, MD
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副研究员：
- Ranjan Kachru, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or Female of age 18 - 75 years
- Incidence of first myocardial infarction
- Acute STEMI with LV hypokinesia involving anteroseptal, lateral or inferior walls
- LVEF < 40% pre-intervention
- Successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow.
- Written informed consent
Exclusion Criteria:
- Multi-vessel coronary disease requiring surgical intervention (CABG) or left main coronary artery disease > 50% blockage
- Previous history of CABG
- Pulmonary edema
- Cardiogenic shock
- Myocarditis
- Renal or hepatic dysfunction
- Hematologic disease
General Exclusion Criteria:
- Alcohol or drug dependency, active or uncontrolled acute myocarditis
- HIV, HBV, or HCV infections
- Evidence of malignant or hematological diseases
- Metal implants of any kind
- Claustrophobia
- Renal insufficiency
- History of bleeding disorder
- Anemia (haemoglobin <8.5mg/dl)
- Platelet count <100,000/ml
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Treatment
Implantation of bone marrow derived mononuclear cells
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Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.
其他名称：
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安慰剂比较：Placebo Control
Infusion of autologous peripheral blood
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Intracoronary infusion of autologous peripheral blood.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of adverse events as a measure of safety
大体时间：12 Months
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Feasibility and safety of Intracoronary infusion of autologous BMMNCs processed through intraoperative point of care technology, freedom from arrhythmia's.
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12 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities.
大体时间：12 Months
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Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities measured by Cardiac MRI and assessed by central Core lab.
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12 Months
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Major adverse cardiac events (MACE)
大体时间：12 Months
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MACE was defined as the composites of any cause of death, myocardial infarction, revascularization of the target vessel, re-hospitalization for heart failure, and life-threatening arrhythmia.
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12 Months
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Quality of life
大体时间：12 Months
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Quality of life assessment is done using short-form 36, Minnesota living with heart failure questionnaire and Seattle Angina Questionnaire
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12 Months
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合作者和调查者
调查人员
- 研究主任：Venkatesh Ponemone, PhD、TotipotentRX Cell Therapy Pvt. Ltd.
- 学习椅：Kenneth Harris, MS、TotipotentRX Cell Therapy Pvt. Ltd.
- 首席研究员：Ashok Seth, FRCP, FACC、Fortis Escorts Heart Institute and Research Centre
- 首席研究员：Upendra Kaul, MD,DM, FACC、Fortis Flt. Lt. Rajan Dhall Hospital
- 首席研究员：Sreenivas A Kumar, MD, DM, FACC、CARE Hospitals, Hyderabad, India
出版物和有用的链接
一般刊物
- Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.
- Strauer BE, Yousef M, Schannwell CM. The acute and long-term effects of intracoronary Stem cell Transplantation in 191 patients with chronic heARt failure: the STAR-heart study. Eur J Heart Fail. 2010 Jul;12(7):721-9. doi: 10.1093/eurjhf/hfq095. Erratum In: Eur J Heart Fail. 2013 Mar;15(3):360.
- Dohmann HF, Silva SA, Sousa AL, Braga AM, Branco RV, Haddad AF, Oliveira MA, Moreira RC, Tuche FA, Peixoto CM, Tura BR, Borojevic R, Ribeiro JP, Nicolau JC, Nobrega AC, Carvalho AC. Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction - MiHeart/AMI study. Trials. 2008 Jul 3;9:41. doi: 10.1186/1745-6215-9-41.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Autologous Bone marrow mononuclear cells的临床试验
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University Health Network, TorontoWomen's College Hospital; Cleveland Clinic Canada尚未招聘