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临床试验/NCT04880538
NCT04880538已完成不适用

Enteric Neural Precursor Cells (ENPC) in the Human Gut - Identification of Molecular Signature and Characterization of Their Proliferative & Neurogenic Potential Using Surgical/Endoscopic Biopsies in Vitro

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Visualization of the network of Nestin+ cells in human gut resection specimens.

研究概览

简要总结

The study aim is to acquire human tissues to (a) understand the structure and organization of the human Enteric Nervous System; (b) perform a molecular transcriptomic profile of individual cells residing in the human gut; (c) study the turnover rates of individual cell types by Fluorescence-activated cell sorting-aided C14 dating of cells; and finally (d) culture the human gut-derived cells characterize the human adult enteric neural stem cell and study its potential for Neuro-glial differentiation. This study will advance our knowledge of the the cellular and molecular correlates of changes in the Enteric Nervous System that are associated with disorders of motility.

详细描述

(i) To study the structure and organization of the human Enteric Nervous System by tissue clarification, immunofluorescence, and 2-photon and light-sheet microscopy.

(ii) To find out the molecular signature that defines various gastrointestinal cells that include the neurons, glia, precursor cells within the Enteric Nervous System and cells associated with the Enteric Nervous System, such as Interstitial Cell of Cajal and macrophages in the human whole gut surgical resection and full thickness endoscopic resection-derived tissues using single cell RNA sequencing and analyses.

(iii) To isolate these cells and study their proliferative and neurogenic potential in vitro and on transplantation into the gut tissue of immunodeficient mice.

(iv) To time stamp and determine the age of Enteric Nervous System cells in adults and determine whether different enteric disease states alter the cycling times of these cells.

(v) To use gut specimens derived from surgical resections and full thickness endoscopic resection-derived tissues for

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking patients in the age range 18 -
  • Patients suffering from Irritable Bowel Syndrome, Inflammatory Bowel Disease, Diabetes, Gastroparesis, will be included.
  • Patients suffering from Collagen disorders such as Alport Syndrome, Ehlers-Danlos Syndrome, Goodpasture Syndrome.
  • Patients suffering from plexiform neurofibromas.
  • Patients with bariatric surgery.
  • Patients with appendicitis.
  • Patients with scleroderma.

排除标准

  • Patients suffering from HIV, Hepatitis C, and other infectious diseases that require the handling of tissues in a Bio-safety level 3 environment.
  • Patients suffering from infectious enteric disorders.
  • Patients without any Gastrointestinal disorders (i.e. healthy volunteers).

结局指标

主要结局

Visualization of the network of Nestin+ cells in human gut resection specimens.

时间窗: Up to one year

Presence or absence of antibodies (including but not limited to) specific to Nestin, p75 neurotrophin receptor, pan-neuronal antibodies, pan-glial antibodies, antibodies against Interstitial Cells of Cajal.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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