跳至主要内容
临床试验/NCT06418256
NCT06418256招募中不适用

Physiology and Pathologies Linked to Human Splenic Function : Direct and Ex-vivo Perfusion Explorations

Assistance Publique - Hôpitaux de Paris5 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
5
主要终点
Refine the understanding of spleen role during infections and conditions of the red blood cell and other human blood cells

研究概览

简要总结

Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options).

详细描述

Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options).

Participation to the study will be proposed to adult patients in whom a splenic intervention (spleno-pancreatectomy, or a total or partial splenectomy) is planned as part of their treatment.

One or more tubes of venous blood collected for the care will be retrieved following the pre- or intra-operative assessment. These samples will serve as controls during analyzes of splenic filtration mechanisms and/or perfusion experiments with populations of altered or modified cells and/or immunological and/or genetic analyses. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Samples from different experimental conditions (for example red blood cell containing malaria parasite for a culture) may be introduced in the perfusion system pour kinetic analyses. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses by cytology, cytometry, histology, immunohistochemistry, electronic microscopy, biochemistry, molecular biology, single cell analyses, on any other method. Peripheral and splenic blood samples or cells, as well as spleen fragments will be stored in. a biobank for further use or experimental analyses.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients
  • •Patient requiring left splenopancreectomy or planned splenectomy regardless of the method or indication

排除标准

  • •- The patient notified his doctor of his refusal to recover his spleen and blood volume

结局指标

主要结局

Refine the understanding of spleen role during infections and conditions of the red blood cell and other human blood cells

时间窗: Day 0

Ability of the isolated-perfused human spleen to filter altered cell populations.

次要结局

  • Exploring splenic immunological mechanisms(Day 0)
  • Kinetics of splenic clearance of altered or modified circulating elements(Day 0)
  • Exploring splenic clearance mechanisms(Day 0)
  • Exploring the genetic control of spleen function(Day 0)
  • Explore the impact of preservation processes on organ and cell functions, as well as engraftment(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

Loading locations...

相似试验

Physiology and Pathologies Linked to Human Splenic... | 临床试验