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Isolation and Characterization of Endothelial Colony Forming Cells (ECFCs) in Patients Diagnosed With Von Willebrand Disease, Acquired Von Willebrand Syndrome and Healthy Subjects

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

⁃ 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.

• 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.

Locations
Other Locations
Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, A.B.Bonomi Hemophilia and Thrombosis Center
RECRUITING
Milan
Contact Information
Primary
Flora Peyvandi, MD, PhD
flora.peyvandi@policlinico.mi.it
02-55035414
Time Frame
Start Date: 2023-11-11
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 48
Treatments
von willebrand disease/ Acquired von Willebrand disease patients
Patients with a confirmed diagnosis of VWD or AVWS. Participants will undergo peripheral blood sample collection for plasma VWF measurements and ECFCs isolation and characterization. In patients with VWD without prior molecular characterization, an additional blood sample will be collected for genetic analysis.
Healthy donors
Healthy volunteers with no personal or family history of bleeding or thrombotic disorders, serving as the reference population for the study. Participants will undergo peripheral blood sample collection plasma VWF measurements and ECFCs isolation and characterization.
Sponsors
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov