Origin of CEC in Patients After Allo-HSCT

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

Detailed Description
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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.

Official Title
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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

Conditions
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Graft Versus Host Disease, Acute, Endothelial Dysfunction, Immune Tolerance

Intervention / Treatment
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* Diagnostic Test: D-CEC counting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: D-CEC counting|By means of preliminary bulk separation step with the CellSearch system, single CEC will be sorted|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating Endothelial Cells, Graft versus Host Disease, Neovascularization, Allotransplantation