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Red Cell AlloantibodiesNCT07480980

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

An observational study of Red Cell Alloantibodies and Blood Transfusion-Dependent, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial 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. Read more about this study

Who is it for?
Any age
How many people
100 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 1 Jul 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Asmaa Mohamed Elsayed, Assistant lecturer contact

01027575354

Momenasmaa392@gmail.com

About this study

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).

Read more

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.

Read the detailed description

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.

Medical subject headings
beta-Thalassemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At the time of patient enrollment

Secondary outcomes (1)
  1. Frequency of red cell alloantibodies

    Detection and identification of red blood cell alloantibodies in transfusion-dependent patients using standard immunohematological techniques.

    Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07480980
Sponsor's protocol ID
MIR155-ALLO-TDT-2026
Status last verified
Mar 2026
First submitted
14 Mar 2026
Last updated
6 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

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