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临床试验/NCT05294107
NCT05294107招募中不适用

Intestinal Organoids

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Number of isolated intestinal crypts per biopsies

研究概览

简要总结

Over the last decade, the use of mini-organ or organoids has been increasingly developed in fundamental research. Indeed, digestive organoids represent an essential advance compared to classical culture systems (epithelial cell lines, immortalized cells) since they preserve in culture the functional complexity present in vivo (architecture, different cell types). They also have the advantage of being able to be propagated indefinitely (unlike explants), minimizing the use of animal models and reducing the amount of tissue required. Finally, their growth and development depends on the origin of the sample (the organoid will develop differently if the cell source comes from a patient suffering from an inflammatory bowel disease, for example), thus generating models of human pathologies to better determine their physiopathology. The use of organoids in biomedical research has proven to be an indispensable tool for the understanding of cellular and molecular mechanisms involved in epithelial renewal and the screening of molecules and ingredients for applications in the health and agri-food sectors.

详细描述

The project aims to generate a biocollection of 3D intestinal models from digestive biopsies with associated health data and to characterize them before using them for the screening of potential therapeutic molecules.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 18 to 75 years
  • Subject undergoing endoscopy as part of the standard of care with the need to take digestive biopsy samples
  • Subject having signed a free and informed consent in writing

排除标准

  • Subjects under legal protection (safeguard of justice, curatorship or guardianship) or deprived of liberty.
  • Anticoagulant treatment and anti-platelet treatment (except for aspirin 75 mg)

研究组 & 干预措施

Group Crohn's disease

Experimental

4 additional biopsies for 30 patients with Crohn's disease

干预措施: additional biopsies (Procedure)

Group ulcerative colitis

Experimental

4 additional biopsies for 30 patients with ulcerative colitis

干预措施: additional biopsies (Procedure)

Group No MICI

Active Comparator

4 additional biopsies for 30 patients out of Inflammatory Disease Chronic Bowel Disease

干预措施: additional biopsies (Procedure)

结局指标

主要结局

Number of isolated intestinal crypts per biopsies

时间窗: Day 0

Biopsies will be then prepared by isolating intestinal crypts and cultured on a 3D matrix gel (matrigel) with added growth factors reproducing the niche environment of intestinal stem cells, which favors the development of an intestinal epithelium. After intestinal differentiation, organoids will be used for research such as molecular screening, assessment of the effects of intestinal stress and healing.

次要结局

  • Number of differentiated organoids(Day 0)
  • Fold change of MUC2 expression(Day 0)
  • Fold change of LGR5 expression(Day 0)
  • KI67 expression(Day 0)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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