Origin of CEC in Patients After Allo-HSCT — DCEC-PIANO  

Endothelial Dysfunction Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Acute Disease
• Endothelial Dysfunction
• Graft Versus Host Disease, Acute
• Graft vs Host Disease
• Immune Tolerance

• NCT number: NCT04038827
• Study type: Observational
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Status: Completed
• Start date: August 27, 2019
• Completion date: April 30, 2020