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临床试验/NCT04038827
NCT04038827已完成不适用

Search of Circulating Endothelial Cells of Donor Origin After Allogeneic Hematopoietic Stem Cell Transplantation: Evaluation for Potential Clinically Relevant Implications in the Context of Graft-Versus-Host Disease

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年8月27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
15
试验地点
1
主要终点
Presence of D-CEC at time of engraftment in patients undergoing allo-HSCT

研究概览

简要总结

We believe that CEC, besides coming from cells shedding from patient vasculature, could partly belong to donor, originating from the cellular graft.

详细描述

In consideration of the fact that the vascular endothelium has been shown to be a target of GvHD in early stage and that the count of CEC represent a marker of endothelial damage, we want to correlate the presence of donor CEC at engraftment with a putative protective function against GVHD manifestations. We will enroll patients affected by hematologic disorders undergoing allo-HSCT. At time of engraftment and at + 3 months after allo-HSCT, CEC identified and counted by means of the CellSearch system, will be recovered from the counting cartridge and further sorted at the single cell level. STR profile of each single CEC recovered will be performed in order to define host versus donor origin of each CEC analysed.

Through the conduct of this study, we expect to upfront identify patients who will or will not manifest GvHD. This result will allow definitely different clinical approaches: stringent monitoring and early therapeutic intervention, before refractory disease's development, in the formers, while, sparing unnecessarily expensive testing or heavier treatment in the latters.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing allo-HSCT for their neoplastic hematologic diseases
  • written informed consent
  • achievement of hematopoietic recovery from aplasia post-allo-HSCT
  • predictable life expectancy > 6 months

排除标准

  • presence of active malignant hematologic disease at time of allo-HSCT

结局指标

主要结局

Presence of D-CEC at time of engraftment in patients undergoing allo-HSCT

时间窗: Within 30 days from allo-HSCT

Single CEC will be isolated and STR profile determined

Correlate presence/absence of D-CEC with GVHD manifestations

时间窗: day +100 post allo-HSCT

D-CEC presence will be correlated with GVHD onset

次要结局

  • Presence of donor CEC embedded in the endothelial layer of patients microvasculature at late timepoint after allo-HSCT(day +100 post allo-HSCT)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Camillo Almici MD

Director of the Stem Cells Lab

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

研究点 (1)

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