Endothelial Colony-Forming Cells in Patients With VWD, AVWS and Healthy Subjects (NCT07358013) | Clinical Trial Compass
RecruitingNot Applicable
Endothelial Colony-Forming Cells in Patients With VWD, AVWS and Healthy Subjects
Italy48 participantsStarted 2023-11-11
Plain-language 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.
Who can participate
Age range16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
ECFCs isolation and characterization
Timeframe: 42 weeks from enrollment start
Trial details
NCT IDNCT07358013
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico