Presence of Circulating Cluster of Differentiation 4 Positive 28 Null T Helper Lymphocytes(CD4+CD28-) in Patients With Autoimmune Hemolytic Anemia.

NCT ID: NCT05711264

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2025-04-01

Brief Summary

1. Study the presence of circulating CD4+/CD28 null T lymphocytes in AIHA either Idiopathic or Secondary.

2. Role of CD4+/CD28 null T lymphocytes in monitoring response to therapy in AIHA.

Detailed Description

Autoimmune hemolytic anemia (AIHA) has always been considered the simplest and most scholastic example of antibody-mediated autoimmune disease.It has been identified as a greatly heterogeneous disease, due to several immunological mechanisms involved beyond antibodies, complement and antibody-dependent cell-mediated cytotoxicity (ADCC). AIHAs may be Idiopathic of unknown cause Secondary associated with several conditions : (lymphoproliferative, autoimmune , infectious diseases, immunodeficiencies, solid tumors, transplants, and drugs).Several subsets of T and B lymphocytes with highly specialized functions have been characterized. Some lymphocytes promote inflammation, while others have anti-inflammatory roles, and an optimal balance between these two opposing sets of lymphocytes is critical for immune homeostasis. A pro-inflammatory subset of CD4+ T helper 1 (Th1) lymphocytes known as cluster of differentiation 4 positive 28 negative T helper lymphocytes (CD4+CD28 null T cells) because they characteristically lack CD28 which is a co-stimulatory receptor critical for the activation and function of T cells.CD4+CD28 null T cells are rare in healthy individuals, but they increase in inflammatory and immune-mediated diseases. Prevalence of CD4+CD28 null T cells is high in chronic inflammatory diseases, autoimmune diseases, immunodeficiency and specific infectious diseases.It remains controversial whether CD4+CD28null T cells are antigen specific and which are the precise antigens that trigger their expansion. It has been suggested that CD4+CD28null T lymphocytes are auto-reactive and that repeated stimulation by auto-antigens drives the expansion of this cell subset.Expansion of the CD4+CD28 null T-cell subset in patients affected by autoimmune disorders has been linked to the severity of disease and an unfavourable prognosis.

Conditions

Autoimmune Hemolytic Anemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 1- newly diagnosed patients with AIHA 2- patients with idiopathic or secondary AIHA

Exclusion Criteria

• 1-current steroid therapy 2- other concurrent chronic inflammatory conditions 3-recent blood transfusion 4- active Hepatitis C virus

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amira Ehab Salah Eldin

Resident in clinical pathology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Amira ehab

Role: CONTACT

amira.ehab99@yahoo.com

01005305860

Nada Osman, lecturer

Role: CONTACT

drnadaosman911@gmail.com

01066937438

References

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Reference Type: BACKGROUND

PMID: 26696796 (View on PubMed)

Youssef SR, Elsalakawy WA. First report of expansion of CD4+/CD28 null T-helper lymphocytes in adult patients with idiopathic autoimmune hemolytic anemia. Hematol Transfus Cell Ther. 2021 Oct-Dec;43(4):396-401. doi: 10.1016/j.htct.2020.04.010. Epub 2020 Jul 16.

Reference Type: BACKGROUND

PMID: 32709527 (View on PubMed)

Fattizzo B, Barcellini W. Autoimmune Cytopenias in Chronic Lymphocytic Leukemia: Focus on Molecular Aspects. Front Oncol. 2020 Jan 10;9:1435. doi: 10.3389/fonc.2019.01435. eCollection 2019.

Reference Type: BACKGROUND

PMID: 31998632 (View on PubMed)

Jager U, Barcellini W, Broome CM, Gertz MA, Hill A, Hill QA, Jilma B, Kuter DJ, Michel M, Montillo M, Roth A, Zeerleder SS, Berentsen S. Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting. Blood Rev. 2020 May;41:100648. doi: 10.1016/j.blre.2019.100648. Epub 2019 Dec 5.

Reference Type: BACKGROUND

PMID: 31839434 (View on PubMed)

Broux B, Markovic-Plese S, Stinissen P, Hellings N. Pathogenic features of CD4+CD28- T cells in immune disorders. Trends Mol Med. 2012 Aug;18(8):446-53. doi: 10.1016/j.molmed.2012.06.003. Epub 2012 Jul 10.

Reference Type: BACKGROUND

PMID: 22784556 (View on PubMed)

Thewissen M, Somers V, Hellings N, Fraussen J, Damoiseaux J, Stinissen P. CD4+CD28null T cells in autoimmune disease: pathogenic features and decreased susceptibility to immunoregulation. J Immunol. 2007 Nov 15;179(10):6514-23. doi: 10.4049/jimmunol.179.10.6514.

Reference Type: BACKGROUND

PMID: 17982040 (View on PubMed)

Other Identifiers

CD4+CD28- Lymphocyte IN AIHA

Identifier Type: -

Identifier Source: org_study_id