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临床试验/NCT07480980
NCT07480980尚未招募不适用

Evaluation of Micro RNA-155 Expression in Relation to Alloantibody Formation in Transfusion-Dependent Patients

Assiut University0 个研究点目标入组 100 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Relative expression level of microRNA-155

研究概览

简要总结

Transfusion-dependent patients, particularly those with β-thalassemia major, require lifelong regular red blood cell (RBC) transfusions to maintain adequate hemoglobin levels and prevent severe anemia. Although transfusion therapy significantly improves survival and quality of life, it is associated with several immunological complications, the most important of which is red cell alloimmunization. Alloimmunization occurs when the recipients immune system recognizes foreign antigens on donor RBCs and produces alloantibodies against them, which may lead to hemolytic transfusion reactions, difficulty in finding compatible blood and increased transfusion requirements (1). The incidence of RBC alloimmunization in transfusion-dependent patients varies widely but remains a major clinical challenge in transfusion medicine (2).

Recent advances in molecular hematology have highlighted the importance of microRNAs (miRNAs) in regulating immune responses and hematopoiesis. MicroRNAs are small non-coding RNA molecules that regulate gene expression at the post-transcriptional level and play a key role in both innate and adaptive immunity (3). Among them, microRNA-155 (miR-155) has emerged as a critical regulator of inflammatory pathways, antigen presentation, and lymphocyte activation. It modulates immune cell differentiation and cytokine production, thereby influencing immune responses to foreign antigens (4, 5).

In patients with β-thalassemia, miR-155 is also implicated in erythropoiesis and ineffective red cell production, suggesting its involvement in both hematologic and immunologic pathways of the disease. Increased expression of miR-155 has been reported in thalassemic erythroid cells and is associated with altered erythroblast proliferation and differentiation (6).

Importantly, recent studies suggest that miR-155 may contribute to the development of alloimmunization in transfusion-dependent patients.

详细描述

Transfusion-dependent patients, particularly those with β-thalassemia major, require lifelong regular red blood cell (RBC) transfusions to maintain adequate hemoglobin levels and prevent severe anemia. Although transfusion therapy significantly improves survival and quality of life, it is associated with several immunological complications, the most important of which is red cell alloimmunization. Alloimmunization occurs when the recipients immune system recognizes foreign antigens on donor RBCs and produces alloantibodies against them, which may lead to hemolytic transfusion reactions, difficulty in finding compatible blood and increased transfusion requirements (1). The incidence of RBC alloimmunization in transfusion-dependent patients varies widely but remains a major clinical challenge in transfusion medicine (2).

Recent advances in molecular hematology have highlighted the importance of microRNAs (miRNAs) in regulating immune responses and hematopoiesis. MicroRNAs are small non-coding RNA molecules that regulate gene expression at the post-transcriptional level and play a key role in both innate and adaptive immunity (3). Among them, microRNA-155 (miR-155) has emerged as a critical regulator of inflammatory pathways, antigen presentation, and lymphocyte activation. It modulates immune cell differentiation and cytokine production, thereby influencing immune responses to foreign antigens (4, 5).

In patients with β-thalassemia, miR-155 is also implicated in erythropoiesis and ineffective red cell production, suggesting its involvement in both hematologic and immunologic pathways of the disease. Increased expression of miR-155 has been reported in thalassemic erythroid cells and is associated with altered erythroblast proliferation and differentiation (6).

Importantly, recent studies suggest that miR-155 may contribute to the development of alloimmunization in transfusion-dependent patients.

Therefore, investigating the association between miR-155 expression and RBC alloimmunization may provide valuable insights into the molecular mechanisms underlying immune dysregulation in transfusion-dependent patients and may help identify novel biomarkers for predicting alloimmunization risk.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 1- Confirmed transfusion-dependent . 2-Regular RBC transfusion history 3- Age ≥5 years

排除标准

  • 1- Autoimmune diseases 2- Active infections or inflammatory conditions. 3- Immunosuppressive therapy Ý

结局指标

主要结局

Relative expression level of microRNA-155

时间窗: At the time of patient enrollment

Assessment of the relative expression level of microRNA-155 in transfusion-dependent patients with red cell alloimmunization compared with non-alloimmunized transfusion-dependent patients using quantitative real-time PCR.

次要结局

  • Frequency of red cell alloantibodies(At enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa mohamed elsayed mohamed

Dr. Asmaa Mohamed, PhD Candidate, Hematology Department, Faculty of Medicine, Assiut University, Egypt

Assiut University

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