Observational Study of Extracellular Vesicles in Gaucher Disease

This is an observational study looking at Gaucher disease. Researchers want to understand how problems with lysosomes (small parts of cells that break down waste) might affect tiny particles called extracellular vesicles (EVs). They are studying the quantity and size of these EVs in people with Gaucher disease, carriers of the Gaucher gene, and healthy individuals. The goal is to see if changes in EVs could help identify new ways to understand and track Gaucher disease, especially since EVs can cross into the brain. They will measure EV quantity at the start and after 3 months, and EV size at the start. You can join if you are between 18 and 80 years old, have a confirmed Gaucher diagnosis, are a confirmed carrier, or are a healthy control without the GBA1 gene mutation. The study is currently recruiting about 30 participants.

Study design
This is an observational study with no intervention, meaning participants will not receive any new treatments. It plans to enroll about 30 participants.
What's involved
EV quantity will be measured at baseline and again at 3 months. EV size will be measured at baseline.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 3 months, based on the endpoint measurements.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05843552

Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease

Recruiting
Not specifiedAges 18–80Observational
University of Minnesota
~30 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:no intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
EVs quantity
Measured over baseline
+5 more outcomes measured
Gaucher Disease

NCT05843552

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Minnesota

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Reena Kartha, PhD, MS · PRINCIPAL_INVESTIGATOR · University of Minnesota
  • Subbaya Subramanian, PhD, MS · PRINCIPAL_INVESTIGATOR · University of Minnesota

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • EVs quantitybaseline

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

  • EVs quantity3months

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

  • EVs sizebaseline

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

  • EVs size3months

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

  • EVs contentbaseline

    Examine contents in vesicles isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.

  • EVs content3months

    Examine contents in vesicles isolated from plasma samples collected from patients with GD and carriers and compare to healthy individuals.