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Extracellular Vesicles as Stroke Biomarkers

NCT05370105 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2025-02-03

No results posted yet for this study

Summary

The combination of rehabilitation protocols and regenerative therapies offers the outstanding opportunity to promote and enhance the endogenous regenerative and repair processes occurring in tissues damaged or lost due to injury, disease, or age. Still, one of the main hurdles in the clinical approach to regenerative rehabilitation is the lack of easily accessible and sensitive biomarkers for the evaluation of rehabilitation and therapy efficacy. Extracellular vesicles (EVs) are nanoscaled vesicles that mediate intercellular communication among organs. EVs were shown to be involved in the onset, progression and resolution of many disorders, being also used as valuable tool in the regenerative medicine field. However, the initial enthusiastic approach to EVs has been hindered in its transfer to clinics because of technological obstacles related to their dimensions and to their limited amount. The present project proposes the application of a Surface Plasmon Resonance imaging (SPRi)-based biosensor for the detection and characterization of blood EVs from stroke patients, before and after rehabilitation. After the successful SPRi detection of EVs of different cellular origin (brain and non-brain cells), the quantification of specific surface molecules related to pathological or regeneration processes will be accomplished. If successful, the project will 1) demonstrate the ability of the SPRi biosensor to reveal differences in the relative amount of specific cell-derived EV subpopulations and in their cargo during disease progression and rehabilitation induced recovery, 2) provide support for using the proposed SPRi-based biosensor for the detection and characterization of circulating EVs in order to evaluate the efficacy of rehabilitation protocols and regenerative therapies, 3) identify new biomarkers for the profiling of stroke patients to personalize the rehabilitation therapies.

Conditions

Interventions

OTHER

blood withdrawal

10 ml of blood, two 5 ml tubes suitable for serum isolation. Given the nature and objectives of the study, there are no risks and / o inconveniences of particular importance for the patient since the blood samples will be performed according to the common procedure used in all analysis laboratories. At the end of the collection, in the area where the blood sample was taken, a small bruise may form which will disappear in the following hours, in any case during the collection particular attention will be paid to the subjects being treated with antiplatelet and anticoagulants. The study does not include the execution of interventional treatments or therapies.

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Alice Gualerzi, PhD · Fondazione Don Carlo Gnocchi, Laboratory of Nanomedicine and Clinical Biophotonics

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-25
Primary Completion
2022-09-30
Completion
2023-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05370105 on ClinicalTrials.gov