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Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells

NCT03043677 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2019-02-25

No results posted yet for this study

Summary

To characterize circulating DC subsets from healthy controls and IBD patients and to assess, following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators on both the GI production of soluble immune mediators and the mucosal capacity to alter the recruitment capacity of circulating DC subsets. It is expected that such approach will provide further information on the action mechanisms of such therapies on IBD patients, allowing a better understanding of the pathophysiology of this disease and the identification of tissue-specific therapeutic targets, thus avoiding collateral problems associated with systemic immunomodulation.

Conditions

Interventions

BIOLOGICAL

Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab

Ex-vivo conditioning of lamina propria and peripheral blood mononuclear cells. Here, we will address whether the current available biological therapies for IBD patients (infliximab, golimumab, adalimumab, vedolizumab and ustekinumab) elicit a differential effect on the mucosal capacity to recruit circulating leukocytes on an ex-vivo approach using transwell culture systems.

Sponsors & Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2017-12-31
Completion
2018-05-30
FDA Drug
Yes

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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 NCT03043677 on ClinicalTrials.gov