Anti-inflammatory Cells in Peritoneal Cavity

Chronic Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03189316
• Other study ID #: 9828
• Status: Terminated
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: December 13, 2017

Study information

• Verified date: June 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 13, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Ovarian Cysts
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
France	CHU montpellier - department of rheumatology	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative percentage of regulatory B cells among B cells in peritoneal cavity compared to peripheral blood	Comparison of Breg cell in peritoneal cavity to Breg cell in peripheral blood B	up to 48 hour