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Clinical Trials in Italy / NCT07358013
Recruiting Observational

Endothelial Colony-Forming Cells in Patients With VWD, AVWS and Healthy Subjects

NCT07358013 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase
Observational
Started
2023-11-11
Last updated
2026-01-22

Condition(s) studied

Von Willebrand Disease (VWD)Acquired Von Willebrand Disease

Investigational drug(s) / intervention(s)

Blood sample collection for VWF measurements in plasmaBlood sample collection for ECFC isolation and characterizationGenetic testing of VWF

Blood sample collection for VWF measurements in plasma: Plasma samples will be collected for the measurement of VWF levels.

Blood sample collection for ECFC isolation and characterization: Blood samples will be collected to isolate ECFCs and perform their subsequent characterization.

Genetic testing of VWF: An additional blood sample will be collected for VWF genetic testing in patients with VWD without prior molecular characterization.

Study summary

The goal of this observational study is to learn how endothelial colony-forming cells (ECFCs) behave in people with von Willebrand disease (VWD), acquired von Willebrand syndrome (AVWS), and in healthy individuals.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria for patients: Patients with von Willebrand disease (VWD) or acquired von Willebrand syndrome (AVWS) Age ≥ 16 years. Previous diagnosis of von Willebrand disease or acquired von Willebrand syndrome, defined as one of the following: Group A - Type 1 VWD: VWF levels ≤ 30 IU/dL, regardless of bleeding history, or VWF levels ≤ 0.50 IU/mL in the presence of abnormal bleeding. Group B - Congenital or acquired VWD (VWD or AVWS): Diagnosis of congenital or acquired VWD, with or without gastrointestinal bleeding. Group C - Subgroup study (Type 2A VWD): One patient with type 2A VWD selected for a dedicated sub-study involving allele-specific siRNA silencing of the mutant allele. Ability and willingness to provide written informed consent. For patients without prior molecular characterization: willingness to undergo VWF gene sequencing and to sign the related informed consent. Inclusion criteria for healthy volunteers * No prior diagnosis of VWD, bleeding disorders, or thrombotic disorders. * Willingness to donate blood for study procedures. * Ability and willingness to provide written informed consent. * Age ≥ 18 years. Exclusion criteria for both patients and healthy volunteers: * Pregnancy. * Anemia, as determined at screening or based on medical history.

Primary outcome measure(s)

  • ECFCs isolation and characterization — 42 weeks from enrollment start
    Assessment of differences between ECFCs derived from patients with VWD or AVWS and healthy controls. Basal and stimulated VWF production and secretion by ECFCs, including basal VWF levels in culture media and cell lysates and stimulated VWF release following exposure to biological or chemical compounds, measured by ELISA (IU/dL) and compared between patients with VWD/AVWS and healthy controls. VWF mRNA expression levels in ECFCs, assessed by quantitative real-time PCR and expressed as ΔΔCt, compared between patients with VWD/AVWS and healthy controls.

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, A.B.Bonomi Hemophilia and Thrombosis Center Milan Italy Recruiting

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Other trials for the same condition

Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD) Recruiting
A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07358013 on ClinicalTrials.gov ↗ ← All trials in Italy