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The main objective of the project is therefore to study and thus better understand the immunomodulatory / anti-inflammatory effects of cladribine during multiple sclerosis. Most current and developing therapies targeting the immune system have no effect on the progressive phase of MS, during which neurodegeneration plays a predominant role. As mentioned above, the very promising results of clinical trials with cladribine tablets for the early and progressive phase of the disease have revealed immunomodulatory properties and suggested potential neuroprotective effects. It therefore plans to further dissect one of these two parameters by designing in vitro studies with peripheral blood mononuclear cells (PBMC) from healthy donors and MS patients.
Recent clinical trials have reported a remarkable therapeutic efficacy of cladribine tablets not only in the early and recurrent phases of the disease, but also in progressive multiple sclerosis. However, its role on the immune and nervous systems has hardly been studied, although these studies suggest that CoA may exert anti-inflammatory and neuroprotective actions. Thus, the objective is to better understand/describe how cladribine acts during MS and to demonstrate whether CoA: (1) is able to effectively modulate pro-inflammatory immune processes and (2) has powerful neuroprotective properties. Ultimately, it will provide proof of concept that cladribine can be used not only in the early but also in the progressive phase of MS. To address this hypothesis, the goal is to study the beneficial immunomodulatory/anti-inflammatory effects of cladribine on multiple sclerosis. The main objective of this project is therefore to study and thus better understand the immunomodulatory / anti-inflammatory effects of cladribine during multiple sclerosis. Most current and developing therapies targeting the immune system have no effect on the progressive phase of MS, during which neurodegeneration plays a predominant role. As mentioned above, the very promising results of clinical trials with cladribine tablets for the early and progressive phase of the disease have revealed immunomodulatory properties and suggested potential neuroprotective effects. It therefore plans to further dissect one of these two parameters by designing in vitro studies with peripheral blood mononuclear cells (PBMC) from healthy donors and MS patients.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Rouen University Hospital
Rouen, France
Start Date
July 13, 2020
Primary Completion Date
December 14, 2021
Completion Date
December 14, 2021
Last Updated
February 18, 2026
77
ACTUAL participants
biological collection
OTHER
Lead Sponsor
University Hospital, Rouen
NCT06276634
NCT07225504
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06809192