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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03189316
Other study ID # 9828
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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