Extracellular Vesicle-based Strategy to Stratify Islets and Improve Their FItness Before Transplantation (EVIFIT)
Islet transplantation restores glucose tolerance in people living with diabetes characterised by high glycaemic variability: 90 per cent of patients were free from severe hypoglycaemia at 5 years, compared with 26 per cent prior to transplantation, and 50 per cent of patients were insulin-independent at 1 year. However, follow-up of participants is characterised by a gradual loss of islet function, with only 30 per cent of patients remaining insulin-independent at 5 years.
The greatest limitation and challenge of islet transplantation lies in the substantial loss of islet mass infused via the portal vein at the start of the post-transplant period. Up to 50 per cent of the graft may be lost in the days following transplantation. This early loss is due to a combination of stress and non-specific inflammatory and immune mechanisms, as well as blood-mediated inflammatory reactions, which compromise the survival, engraftment, revascularisation and early function of the transplanted islets. Consequently, multiple islet infusions are often required to achieve satisfactory metabolic outcomes in recipients. However, due to the scarcity of available donors, the widespread application of islet transplantation remains limited as a result. During the culture period, cells in the islet preparation release extracellular vesicles (EVs) - either secreted by the plasma membrane (microvesicles, MVs) or of intracellular endosomal origin (exosomes) - which play a major role in intercellular communication. Microvesicles carry various markers and effectors that can render them either harmful (pro-coagulant, pro-apoptotic, pro-inflammatory and pro-senescent) or protective. We therefore hypothesise that (1) EVs released during the preparation of islets prior to transplantation (hereinafter referred to as Graft-EVs) reflect the quality of the pancreatic islets, (2) certain EVs have a protective or deleterious effect on the pancreatic islet, and (3) reconditioning the islets by enriching them with protective EVs improved graft quality under the pro-inflammatory conditions of IBMIR.
We therefore propose to develop an EV-based islet preconditioning strategy to improve graft survival and function.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Cécile Arnold
- 电话号码:0033 3 88 11 51 48
- 邮箱:cecile.arnold@chru-strasbourg.fr
学习地点
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Strasbourg、法国、67200
- Hopitaux Universitaires de Strasbourg
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接触:
- Laurent MEYER, MD
- 邮箱:laurent.meyer@chru-strasbourg.fr
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接触:
- Laurence KESSLER, MD
- 邮箱:kesslerl@unistra.fr
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Adult patients with no upper age limit
- Men or women
- Patients with type 1 diabetes
- Patients on the waiting list for a pancreatic islet transplant (Agence de Biomédecine)
- Patients who have given their consent for their data to be reused for the purposes of this research
Exclusion Criteria:
- Pregnant women
- Patients under guardianship or administration
- Individuals subject to judicial protection measures
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Patient with type 1 diabetes on the waiting list for a pancreatic islet transplant
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The BETA-2 score enables the detection of insulin independence following islet transplantation (BETA-2 score < 20) with a specificity and sensitivity of over 82 per cent.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Primary function of the graft measured one month after the last islet injection (beta2score)
大体时间:1 month after the last islet injection
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1 month after the last islet injection
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Using the criteria for graft success (IGLS score)
大体时间:one and two years post-transplant in recipients
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one and two years post-transplant in recipients
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合作者和调查者
调查人员
- 首席研究员:Laurent MEYER、Hopitaux Universitaires de Strasbourg
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
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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