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.
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
- Conditions the study is for
- Red Cell Alloantibodies, Blood Transfusion-Dependent, Beta Thalassemia
- 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.
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.
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)
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.
- First posted18 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Red Cell AlloantibodiesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa mohamed elsayed mohamed, Assiut University
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.