Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT05843552

Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease

Led by University of Minnesota · Updated on 2026-04-06

30

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18-80 years
  • Participants must be untreated patients with Gaucher disease, obligate carriers of the GBA1 mutation, or healthy controls
  • Gaucher disease diagnosis must be confirmed for patients
  • GBA1 mutation must be confirmed for carriers
  • Healthy controls must have no GBA1 mutation confirmed by gene sequencing
Not Eligible

You will not qualify if you...

  • Participants with any hematological malignancy or other uncontrolled comorbid conditions
  • Participants currently receiving therapy for Gaucher disease

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

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Research Team

R

Reena Kartha, PhD, MS

CONTACT

M

Marcia Terluk, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease | DecenTrialz