IL37,Tlymphocytes,NK Cells in Pathogenesis of ITP

ITP Clinical Trial

Official title:

IL37,Tlymphocytes ,NK Cells in Pathogenesis of Immune Thrombocytopenia.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04482777
• Other study ID #: Cellular immunity in ITP
• Status: Not yet recruiting
• Start date: July 30, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2023
• Source: Assiut University
• Contact: Asmaa Mohamed
• Phone: 01027575354
• Email: mohamedasmaa550[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the role of IL37 in pathogenesis of ITP and to study the relation between IL37,Tlymphocytes,NK cells in ITP

Description:

Idiopathic thrombocytopenia or immune thrombocytopenia (ITP) is a hematological condition which is characterized by a low platelet count of less than 100 x 109L . Symptoms of ITP can vary but tend to be symptoms of thrombocytopenia in general, such as petechiae, purpura, mucosal bleeding and in the most severe cases fatal intracranial hemorrhage(1,2) Interleukin (IL)-37, a novel anti-inflammatory cytokine previously known as interleukin-1 family member 7 before it was renamed, has a pivotal role in the suppression of immune responses (3,4). IL-37 is widely expressed in several types of cells, tissues and organs, including peripheral blood mononuclear cells (PBMCs) (5). The major role of IL-37 is to decrease excessive inflammation in innate and adaptive immune diseases, mainly by inhibiting the expression, production and function of pro-inflammatory cytokines, including IL-1α, IL-6, tumor necrosis factor (TNF) and macrophage inflammatory protein-2. The abundance of these cytokines has been reported to increase with the silencing of endogenous IL-37 in human blood cells (3,6).Aberrant expression of IL-37 has been observed in several inflammatory and autoimmune diseases However, the role of IL-37 in ITP has remained elusive. Immune thrombocytopenia pathogenesis is a complicated process. T cell immune abnormalities are involved in ITP pathogenesis. These abnormalities include platelet auto-antigen reactive cytotoxic T cells, abnormal numbers and functions of T regulatory cells, loss of Th1/Th2 balance, megakaryocyte maturation abnormalities and abnormal T cell anergy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Gender: All
• Age group: 2 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with ITP (moderate and sever) different age group.

Exclusion Criteria:

• Patients with stroke and myocardial infarction,malignant tumors or pregnancy.

Related Conditions & MeSH terms

• ITP

Intervention

Drug:
• Corticosteriod for treated patients
Drug given to some patients with autoimmune disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Chen Z, Qu W, Wang HQ, Xing LM, Wu YH, Liu ZY, Zhang Y, Liu H, Dong XF, Tao JL, Shao ZH. [Relationship of Peripheral Blood IL-37 Expression with T Lymphocytes Subsets and NK Cells in Patients with Primary Immune Thrombocytopenia]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2019 Aug;27(4):1201-1207. doi: 10.19746/j.cnki.issn.1009-2137.2019.04.034. Chinese. — View Citation

Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013 Jun;27(3):495-520. doi: 10.1016/j.hoc.2013.03.001. — View Citation

Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17. — View Citation

Zhao Y, Ni X, Xu P, Liu Q, Sun T, Liu X, Ji X, Qiu J, Li J, Wang S, Han P, Peng J, Hou M, Li G. Interleukin-37 reduces inflammation and impairs phagocytosis of platelets in immune thrombocytopenia (ITP). Cytokine. 2020 Jan;125:154853. doi: 10.1016/j.cyto.2019.154853. Epub 2019 Sep 23. Erratum In: Cytokine. 2022 Jul;155:155900. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To decrease the immunity complications in ITP patients	Early detection of immunity complications in ITP patients	Baseline
Primary	To decrease case fatality rate	Early detection of immunity complication will decrease mortality rate	Baseline