Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Minnesota

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • no intervention

    Other intervention

    no intervention, this is an observational study

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: patients with GD1 intervention
Group B: obligate carriers1 intervention
Group C: healthy volunteers1 intervention

Trial outcomes

Primary outcomes

1

EVs quantity

Examine EV quantities isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.

Time frame
baseline
2

EVs quantity

Examine EV quantities isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.

Time frame
3months
3

EVs size

Examine EV sizes isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.

Time frame
baseline
4

EVs size

Examine EV sizes isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.

Time frame
3months

Secondary outcomes

Other outcomes

Sponsors and contacts

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