About this trial
This is an observational study intended to generate preliminary data to understand how lysosomal dysfunction can affect the biogenesis of extracellular vesicles, its content and function. The primary objective of the proposed project is to decipher how extracellular vesicle (EV) biogenesis and its role in intercellular communication can be impaired as a consequence of defects in lysosomal function. Collectively these defects in EV biogenesis and function can contribute to the neuroinflammation observed in lysosomal storage diseases. Since EVs can cross the blood-brain barrier, their characterization may be valuable in identifying novel biomarkers. In the presence of a GBA1 mutation, the decrease in GCase activity will lower overall lysosome function and increase the secretion of EVs. Further, there will be differences in EV size, its cargo including lipids, RNA and proteins and their aggregates. In comparison to healthy controls, EVs isolated from patients with Gaucher disease (GD) and GBA1 carriers is hypothesized to show significant differences in terms of its characteristics and content, which can contribute to our understanding of the link between lysosomes and neurological disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18-80yrs
Restricted to participants who are untreated, obligate carriers and healthy controls.
Participants with GD should have confirmed GD diagnosis, mutation confirmed for carriers and healthy controls confirmed to have no GBA1 mutation by gene sequencing.
Disqualifiers
Exclude participants who have any hematological malignancy or other uncontrolled comorbid conditions.
Exclude participants who are currently on therapy for their GD
Exclude participants who have any hematological malignancy or other uncontrolled comorbid conditions.
Trial population
patients with GD (n=10 untreated), obligate carriers (n=10) and healthy volunteers (frequency matched for age and gender; n=10) for this study. In the next phase of this project, we will examine the effect of GD treatment on EV characteristics by focusing on patients who are currently being treated and compare various therapies and correlate it with established biomarkers.
Trial design
Case-control
Prospective
Treatments tested in this trial
no intervention
Other interventionno intervention, this is an observational study
Treatment groups
Trial outcomes
Primary outcomes
EVs quantity
Examine EV quantities isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.
EVs quantity
Examine EV quantities isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.
EVs size
Examine EV sizes isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.
EVs size
Examine EV sizes isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.
Sponsors and contacts
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