NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults
Immunologic thrombcytopenic purpura (ITP) affects both children and adults. The incidence is estimated in adults about 1,6/100 000/per year. Chronic and relapsing forms of the disease that represent 70% of adult cases are associated with impairment of quality of life related to treatments side effects and bleeding. ITP is secondary to the destruction of circulating platelets through an auto-immune process and to a decrease of platelet production in bone marrow. Auto antibodies are usually directed against epitopes of the GPIIb/IIIa, expressed by platelets. The destruction of the platelets seems to occur mainly in the spleen through antibody dependent cytotoxicity. Both macrophages and cytotoxic T lymphocytes subsets participate to the platelet destruction through the CD16, the low affinity receptor for the Fc of IgG. Thus the CD16 "pathway" is a target for treatments in ITP as for example intravenous immunoglobulins and more recently inhibitors of the syk kinase.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||NK-ITP STUDY : NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURPURA OF ADULTS.|
- Compare NK cells functions, phenotypic changes and transcripts from ITP patients and controls in a case control, multicentric study [ Time Frame: 24 months ] [ Designated as safety issue: No ]Flow cytometry,transcripts.
- Influence of the Ig (IV) treatment on ITP patients' NK cells [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: PTI patients
Study NK cells functions, phenotypic changes and transcripts from ITP patients
|Other: blood samples|
Study NK cells functions, phenotypic changes and transcripts from healthy volunteers
|Other: blood samples|
Natural Killer cells (NK) cells, who are now implicated in the pathophysiology of several autoimmune diseases, express CD16 and display antibody dependent cytotoxicty. Moreover NK cells are present in human spleen. However their role in ITP has not been studied so far. NK could represent a new target for treatments in ITP. We propose thus to conduct a study to characterizes NK cells changes in patients with ITP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172015
|Marseille, France, 13|
|Principal Investigator:||Schleinitz Nicolas||APHM|