CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 177 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03233659
NCT03233659N/ACompleted

Study of the Function of Immune System in Patients Undergoing Allogeneic Stem Cell Transplantation

IRCCS Azienda Ospedaliero-Universitaria di Bologna·observational·Posted Jul 28, 2017·Updated Feb 1, 2023

In Brief

An observational study for Allogeneic Stem Cell Transplantation and GVHD. Completed, enrolled 177 participants across 1 site.

Detailed Summary

Graft versus Host disease ( GVHD) is one of the major complications of Allogeneic Stem Cell Transplantation. Acute GVHD develops early ( within 2to 3 months) after transplantation and is the leading cause of death of transplanted patients. The pathogenesis of Chronic GVHD is still little known. Chronic GVHD is caused by donor T lymphocytes, but we have no precise knowledge on the participation of specific subsets of immune system cells to chronic GVHD. In general, chronic GVHD is associated with an increase in the number of T effector lymphocytes, both helper type 2 and cytotoxic. Recently, also antigen presenting cells (APCs) have been implicated in pathogenesis of chronic GVHD in studies performed on animal models. T lymphocyte responses that characterize chronic GVHD require that recipient antigens are submitted by APCs which originate from the donor's HSC ( Hematopoietic Stem Cells) APCs are heterogeneous population that includes dendritic cells (DCs) ,monocytes, activated B lymphocytes and CD34+ cell subpopulations. These cells can be identified by cytometry. The data about APCs role in chronic GVHD are preliminary and often discordant. Seemingly, there isn't correlation between circulating APCs number and risk of cGVHD. However, recent data of our group show that patients with cGVHD could have higher number of monocytes in bone marrow than transplanted patients without cGVHD. The aim of study is to measure the number of circulating immune cells in the PB (peripherical blood) before and after Allogeneic Hematopoietic Stem Cell Transplantation by flow cytometry.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 28, 2017
Enrollment StartAug 12, 2014
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.9 years ago