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

Autoimmune Hemolytic Anemia Clinical Trial

Official title:

Presence of Circulating CD4+CD28 Null T Helper Lymphocytes in Patients With Autoimmune Hemolytic Anemia.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05711264
• Other study ID #: CD4+CD28- Lymphocyte IN AIHA
• Status: Not yet recruiting
• Start date: January 30, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Amira ehab
• Phone: 01005305860
• Email: amira.ehab99[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: April 1, 2025
• Est. primary completion date: January 30, 2025
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Autoimmune Hemolytic Anemia
• Hemolysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Barcellini W. New Insights in the Pathogenesis of Autoimmune Hemolytic Anemia. Transfus Med Hemother. 2015 Sep;42(5):287-93. doi: 10.1159/000439002. Epub 2015 Sep 7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of CD4+CD28 null T helper lymphocytes in monitoring response to therapy in AIHA using flowcytometry in serum of AIHA patients.	The potential role of CD4+CD28 null T lymphocytes in monitoring response to therapy in AIHA .; the percentage of circulating CD4+CD28 null T helper lymphocytes in AIHA either Idiopathic or Secondary using flowcytometry in serum of AIHA patients.	Baseline