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

Phase 2

Conditions: Aplastic Anemia.
Aplastic anemia, unspecified
D61.9

Registration Number: IRCT20140818018842N29

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 10

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.