Association of Micro RNA-155 With Alloimmunization in Transfusion-Dependent Patients

NCT07480980 | Not Yet Recruiting

• 1 other identifier: MIR155-ALLO-TDT-2026
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Red Cell Alloantibodies; Blood Transfusion-Dependent; Beta Thalassemia

Outcome Measures

Primary Outcomes (1)

• Relative expression level of microRNA-155

  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.

  At the time of patient enrollment

Secondary Outcomes (1)

• Frequency of red cell alloantibodies

  At enrollment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Include patients with chronic blood transfusion and not recive anti immune drugs Not with malignancy diseases

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 1 - Amini MA et al. Association of MicroRNA-155 with Alloimmunization in Transfusion-Dependent Thalassemia Patients. Hemoglobin. 2025. 2- Vamvakas EC, pineda AA. Red cell alloimmunization in transfusion-dependent patients. Transfusion medicine reviews. 2010. 3- Bala S et al. Increased microRNA-155 expression in serum and monocytes during inflammatory responses. J Transl Med. 2012. 4- OConnell RM et al. MicroRNA-155 regulates immune responses and inflammation. J Immunology. 2018. 5- Thai TH et al. miR-155 regulates dendritic cell function and T-cell responses. Cell & Bioscience. 2011. 6- Georgantas RW et al. MicroRNA-155 targets genes involved in hematopoietic differentiation. Proceedings of the National Academy of Science. 2007.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples (5 ml) will be collected from transfusion-dependent patients, both alloimmunized and non-alloimmunized. Samples will be processed to isolate plasma and peripheral blood mononuclear cells (PBMCs). Total RNA, including microRNA, will be extracted and quantified. MicroRNA-155 expression levels will be measured using quantitative real-time PCR. Samples will be stored at -80°C for the duration of the study. No DNA extraction is planned. Biospecimens will be used solely for the purpose of analyzing microRNA-155 expression in relation to red cell alloimmunization.

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Asmaa Mohamed Elsayed, Assistant lecturer

CONTACT

01027575354; Momenasmaa392@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Asmaa Mohamed, PhD Candidate, Hematology Department, Faculty of Medicine, Assiut University, Egypt

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03