Haploidentical hematopoietic stem cell transplantation for the treatment of severe aplastic anemia patients.

Evaluation of the safety and effectiveness of Haploidentical hematopoietic stem cell transplantation for the treatment of severe aplastic anemia patients who lack an Human leukocyte antigen (HLA)-matched (sibling or unrelated) donor.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N29

Enrollment

Registered

2023-01-31

Start date

2023-02-20

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic Anemia. Aplastic anemia, unspecified

Interventions

Intervention group: patients with Severe Aplastic Anemia who are candidates for allogeneic Hematopoietic Cell Transplantation and are between 18-60 years old and are unresponsive to prior immune suppr

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients from 18 to 60 years old Patients with Severe Aplastic Anemia Patients unresponsive to prior immune suppressive treatments. No full matched (sibling or unrelated) donor available.

Exclusion criteria

Exclusion criteria: Prior allogeneic stem cell transplantation Symptomatic coronary artery disease Karnofsky Performance Score < 60 Patients with uncontrolled bacterial, viral or fungal infection A known life-threatening reaction (anaphylaxis) to Thymoglobin. Females who are pregnant or breastfeeding. Patients seropositive for human immunodeficiency virus or active hepatitis B or C with detectable viral load. Received Antithymocyte globulin drug within 2 weeks before enrolling in the study. Previous malignancies other than resected basal cell carcinoma or cervical cancer treated in situ.

Design outcomes

Primary

Measure	Time frame
Overall survival. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient and performing monthly lab tests in outpatient clinique.	—

Secondary

Measure	Time frame
Incidence of acute graft versus host disease. Timepoint: Monthly for 4 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Incidence of chronic graft versus host disease. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Incidence of infectious complications post-transplant. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Transplant Related Mortality. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.	—

Measure

Time frame

Incidence of acute graft versus host disease. Timepoint: Monthly for 4 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Incidence of chronic graft versus host disease. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Incidence of infectious complications post-transplant. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Transplant Related Mortality. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeyla Sharifi Aliabadi

Tehran University of Medical Sciences

ctu@sina.tums.ac.ir00982288004140

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026