Anti-inflammatory Cells in Peritoneal Cavity

June 12, 2018 updated by: University Hospital, Montpellier

Can the Peritoneal Cavity be a Source of Regulatory B Cells to Treat Auto-immune Disease?

Some subsets of lymphocytes are able to inhibit immune response and thus, could be used to control auto-immune diseases and transplant reject. In mice, the main source of those anti-inflammatory lymphocytes is the peritoneal cavity. No data are available in human. This study aims at exploring the presence of those anti-inflammatory lymphocytes in human peritoneal cavity and at determine how to expand those cells.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

B cells will be collected during procedures planned for patients' standard care. Peritoneal fluid and peripheral blood of patients will be collected during coelioscopy for exploration of ovarian cysts or dialysis for treatment of chronic renal insufficiency.

Regulatory B cells (Breg cells) will be measured in peritoneal fluid and in peripheral blood after in vitro stimulation and assessment of intracellular interleukin-10 by flow cytometry. Proportion of Breg cells among B cells will be compared between peritoneal fluid and peripheral blood in both groups.

Different protocols to induce differentiation of B cells into Breg cells will be tested and compared.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU montpellier - department of rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • woman over 18 year old undergoing exploration of ovarian cysts by coelioscopy
  • patient with chronic renal insufficiency undergoing peritoneal dialysis
  • informed consent obtained

Exclusion criteria:

  • pregnancy or breast-feeding
  • non affiliation to health care insurance
  • treatment with corticosteroids over 15 mg/day
  • treatment with rituximab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: subjects with ovarian cyst
Peritoneal fluid sample obtained from coelioscopy for exploration of ovarian cysts and blood sample
Other: peritoneal fluid and blood sample
Peritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample or Peritoneal fluid obtained from coelioscopy for exploration of ovarian cysts and blood cell
Other: subjects with peritoneal dialysis
Peritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample
Other: peritoneal fluid and blood sample
Peritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample or Peritoneal fluid obtained from coelioscopy for exploration of ovarian cysts and blood cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relative percentage of regulatory B cells among B cells in peritoneal cavity compared to peripheral blood
Time Frame: up to 48 hour
Comparison of Breg cell in peritoneal cavity to Breg cell in peripheral blood B
up to 48 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Centre National de la Recherche Scientifique, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2017

Primary Completion (Actual)

December 13, 2017

Study Completion (Actual)

December 13, 2017

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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