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Intra-coronary Versus Intramyocardial Application of Enriched CD133pos Autologous Bone Marrow Derived Stem Cells (AlsterMACS)

2021年8月20日 更新者:Asklepios proresearch

Pilot Study Comparing the Effect of Intra-coronary Versus Intramyocardial Application of Enriched CD133pos Autologous Bone Marrow Derived Stem Cells for Improving Left Ventricular Function in Chronic Ischemic Cardiomyopathy

This is a pilot study comparing the effect of intra-coronary versus intramyocardial application of enriched CD133pos autologous bone marrow derived stem cells for improving left ventricular function in chronic ischemic cardiomyopathy.

研究概览

详细说明

Recent years have seen a tremendous improvement of possibilities to restore normal cardiac perfusion of the coronary arteries both by surgical and interventional techniques. In addition, several pharmacological approaches are available to block the mal-adaptive molecular signaling initiated by the Renin/Angiotensin/Aldosteron (RAAS) system. Device therapy achieving resychronisation has lowered morbidity and mortality. However, heart failure therapy still falls short to address the underlying disease of the heart muscle: loss of contractile force.

To achieve this aim and restore contractile force a regenerative approach is required. Early experimental studies suggested bone marrow cells to be able to differentiate towards functional cardiomyocytes when injected into the scar area after ischemic injury.2 These and other studies lead to clinical trials, where bone marrow cells were injected into the coronary circulation. Lately, the first completed multi-center, placebo-controlled, double-blinded study found several end points to be improved including global left ventricular function 3. At the same time genetically labelled experimental mouse models demonstrated differentiation of bone marrow cells towards a cardiomyocyte lineage to be a rare event,4 questioning at least the proposed molecular and cellular mechanism of intra-coronary cell therapy. Furthermore, several other clinical trials recently performed did either find no or a very limited effect of intra-coronary applied bone marrow cells. The effect appears to be related to improved angiogenesis. Our group has recently shown that in mammals endogenous regeneration of myocardium does occur after injury and can be enhanced via specific signaling pathways.5 Whether intra-coronary cell therapy is the ideal approach to enhance this process is currently unclear.

References:

  1. Nieminen MS, Brutsaert D, Dickstein K, Drexler H, Follath F, Harjola VP, Hochadel M, Komajda M, Lassus J, Lopez-Sendon JL, Ponikowski P, Tavazzi L. EuroHeart Failure Survey II (EHFS II): a survey on hospitalized acute heart failure patients: description of population. Eur Heart J. 2006;27:2725-2736.
  2. Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F, Nadal-Ginard B, Bodine DM, Leri A, Anversa P. Mobilized bone marrow cells repair the infarcted heart, improving function and survival. Proc Natl Acad Sci U S A. 2001;98:10344-10349.
  3. Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Assmus B, Tonn T, Dimmeler S, Zeiher AM, the R-AMII. Intracoronary Bone Marrow-Derived Progenitor Cells in Acute Myocardial Infarction. N Engl J Med. 2006;355:1210-1221.
  4. Murry CE, Soonpaa MH, Reinecke H, Nakajima H, Nakajima HO, Rubart M, Pasumarthi KB, Virag JI, Bartelmez SH, Poppa V, Bradford G, Dowell JD, Williams DA, Field LJ. Haematopoietic stem cells do not transdifferentiate into cardiac myocytes in myocardial infarcts. Nature. 2004;428:664-668.
  5. Zelarayan L, Noack C, Sekkali B, Kmecova J, Gehrke C, Renger A, Zafiriou MP, Nagel Rvd, Dietz R, Windt LJd, Balligand J-L, Bergmann MW. beta-catenin downregulation attenuates ischemic cardiac remodeling through enhanced resident precursor cell differentiation. Proc Natl Acad Sci U S A. 2008;105:19762-19767.
  6. Krause KT, Jaquet K, Geidel S, Schneider C, Mandel C, Stoll HP, Hertting K, Harle T, Kuck KH. Percutaneous endocardial injection of erythropoietin: assessment of cardioprotection by electromechanical mapping. Eur J Heart Fail. 2006;8:443-450.

研究类型

介入性

注册 (实际的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Hamburg、德国、20099
        • Asklepios Klinik St. Georg

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients 18 to 80 years old
  • Of female and male gender
  • Patient has reduced ejection fraction as evaluated by routine clinical angiogram, echocardiography or MRI (≤45%) due to ischemic heart disease
  • symptomatic heart failure NYHA ≥ II on optimal therapy
  • coronary artery in the target region that can be used for cell infusion
  • Patient has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent

Exclusion Criteria:

  • planned or performed CABG surgery or PCI within 4 weeks of study entry
  • recent myocardial infarction (< 6 months)
  • TIMI flow < II in the coronary artery selected for infusion
  • cardiogenic shock requiring mechanical ventilation or intra-aortic balloon pump
  • progressive tumor disease
  • primary disease of bone marrow including mal-function of components of the coagulation system
  • women of child-bearing age premenopausal
  • LV wall thickness < 5mm at planned site of injection
  • ventricular wall thrombus
  • severe aortic valvular heart disease
  • severe atrial or ventricular tachycardia unresponsive to intravenous or oral drug therapy
  • aneurysm of the anterior wall
  • history of stroke
  • know diseases of the liver resulting in reduced plasmatic coagulation with spontaneous INR >2
  • patients with chronic infectious diseases (HBV, HCV, HIV, seropositivity for Treponema pallidum)
  • patients taking part or have taken part in other clinical trials within the past 3 months
  • patients unable to provide informed consent
  • any other medical condition that the enrolling physician deems significant in representing a potential hazard for the patient when participating in this study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:intra-coronary administration
Application of stem cells using the intra-coronary route.
The study aims to show efficacy of both intra-myocardial autologous CD133pos bone marrow cell application as well as intra-coronary CD133pos cell application in patients with symptomatic ischemic heart disease. In addition, efficacy between the two delivery routes will be compared.
实验性的:intra-myocardial administration
Application of stem cells using the intra-myocardial route.
The study aims to show efficacy of both intra-myocardial autologous CD133pos bone marrow cell application as well as intra-coronary CD133pos cell application in patients with symptomatic ischemic heart disease. In addition, efficacy between the two delivery routes will be compared.

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
LVEF
大体时间:after 6 to 12 months
Improvement of global left ventricular function as well as global strain rate as assessed by echocardiography. Transthoracic echocardiography will be performed at baseline and after 6 and 12 month. Images are acquired in the standard parasternal and apical views.
after 6 to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Martin Bergmann, PD Dr.、Asklepios Kliniken Hamburg GmbH

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年7月1日

初级完成 (实际的)

2016年3月2日

研究完成 (实际的)

2017年7月17日

研究注册日期

首次提交

2011年4月14日

首先提交符合 QC 标准的

2011年4月15日

首次发布 (估计)

2011年4月18日

研究记录更新

最后更新发布 (实际的)

2021年8月24日

上次提交的符合 QC 标准的更新

2021年8月20日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1884
  • 2009-013103-63 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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