Origin of CEC in Patients After Allo-HSCT

Completed

• Conditions: Endothelial Dysfunction; Immune Tolerance; Graft Versus Host Disease, Acute

• Registration Number: NCT04038827
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Study Start: 2019-08-27
• Primary Completion: 2020-01-31
• Study Completion: 2020-04-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of D-CEC at time of engraftment in patients undergoing allo-HSCT	Within 30 days from allo-HSCT	Single CEC will be isolated and STR profile determined
Correlate presence/absence of D-CEC with GVHD manifestations	day +100 post allo-HSCT	D-CEC presence will be correlated with GVHD onset

Secondary Outcome Measures

Name	Time	Method
Presence of donor CEC embedded in the endothelial layer of patients microvasculature at late timepoint after allo-HSCT	day +100 post allo-HSCT	CISH analysis will be performed on tissue biopsies at 3 months post-transplant

Trial Locations

Locations (1)

ASST Spedali Civili di Brescia; 🇮🇹 Brescia, Italy