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Extracellular Vesicle-based Strategy to Stratify Islets and Improve Their FItness Before Transplantation (EVIFIT)

2026年9月4日 更新者:University Hospital, Strasbourg, France

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

地位

尚未招聘

干预/治疗

研究类型

观察性的

注册 (估计的)

25

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。

学习联系方式

学习地点

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

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with type 1 diabetes

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

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

队列和干预

团体/队列
干预/治疗
Patient with type 1 diabetes on the waiting list for a pancreatic islet transplant
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.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
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
1 month after the last islet injection
Using the criteria for graft success (IGLS score)
大体时间:one and two years post-transplant in recipients
one and two years post-transplant in recipients

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:Laurent MEYER、Hopitaux Universitaires de Strasbourg

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 (估计的)

2026年9月1日

初级完成 (估计的)

2032年1月1日

研究完成 (估计的)

2032年1月1日

研究注册日期

首次提交

2026年8月31日

首先提交符合 QC 标准的

2026年9月4日

首次发布 (实际的)

2026年9月10日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

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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