The Significance of Release of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune Haemolytic Anemia Before and After Tratment

NCT ID: NCT04814394

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

we study the circulating T-follicular regulatory and T-follicular regulatory cells in autoimmune hemolytic anemia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Autoimmune hemolytic anemia (AIHA) is an acquired autoimmune disease resulting in the production of antibodies directed against the patient's red blood cells (RBCs) causing shortened erythrocyte lifespan.

The main pathogensis of the disease is autoantibodies (Ab) that directed against erythrocytes, with or without complement (C) activation. The most common form of AIHA is warm AIHA characterized by the presence of warm-type autoantibodies-immunoglobulin G (IgG) which reacts optimally at 37 °C, causing RBC extravascular destruction by tissue macrophages .

Previous studies of the etiology and pathogenesis of AIHA have focused on the autoreactive B cells that have escaped tolerance mechanisms and regulatory T cells (Treg).

The main treatment of AIHA includes RBC transfusion and immune system inhibitors such as corticosteroids. During an immune response, CD4 Th cells can differentiate into several unique effector lineages that promote different immune responses via the secretion of distinct types of cytokines.

T follicular helper (Tfh) cells are a CD4 T cell lineage whose major function is to help B cells form germinal centers (GCs) and produce high-affinity antibodies(6). Tfh cells are characterized by expression of the CXCR5, the transcriptional repressor B cell lymphoma 6 (Bcl-6), programmed death 1 (PD-1), and inducible costimulator (ICOS).

Follicular regulatory T (Tfr) cells are a newly identified subset of Treg cells that coexpress markers of both Treg cells and Tfh cells. In addition to expressing Tfh-related markers, Tfr cells also express regulatory markers, such as FoxP3, CD25, CTLA-4, IL-10, and transforming growth factor β (TGFβ).

TFR cells represent a highly specialized subpopulation of Foxp3+ Tregs that co-express TFHfeatures, such as Bcl-6, CXCR5, ICOS, PD-1 and Treg features CD25 and Foxp3. TFR cells have the ability to inhibit TFH activation and cytokines production and suppress B cell GL7 and B7-1 expression and limited class switch recombination occurring in the GC via high expression of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and production of inhibitory cytokine- interleukin 10 (IL-10) and transforming growth factorβ (TGFβ)(5). The involvement of TFR cells in the pathogenesis of human autoimmune diseases remains speculative, but an alteration of the TFR:TFH ratio is observed in the blood of patients suffering from several autoimmune diseases, such as child immune thrombocytopenia, and rheumatoid arthritis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autoimmune Hemolytic Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

flowcytometry

The study of CD4,CD25,FOXP3 and PD-1 on peripheral blood sample

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients diagnosed as autoimmune hemolytic anemia, primary or secondary, male or female, any age but not on treatment

Exclusion Criteria

* Pregnancy or breast-feeding women
* Patients treated with corticoids or immunosuppressant.
* Patients with hematological malignance.
* Patients with alloimmune hemolytic anemia as ABO incompatibility or transplant patients
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed gamal

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

fhraha

Identifier Type: -

Identifier Source: org_study_id