Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT00578903
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Severe Aplastic Anemia (SAA) based on bone marrow aspirate and biopsy results.
2. Failure to respond to immunosuppressive therapy.
3. Lack of an Human Leukocyte Antigen (HLA) identical family member.
4. A 6/6 or 5/6 HLA matched unrelated donor or a 5/6 matched related donor available after high resolution HLA typing.
5. Age from birth to 60 years.
Exclusion Criteria:
1. Severe disease other than aplastic anemia that would limit the probability of survival during the graft procedure. Patients who present with active infection must be treated to maximally resolve this problem before beginning the conditioning regimen.
2. Human immunodeficiency virus (HIV) seropositive patients
3. Patients who have clonal cytogenetic abnormalities or a myelodysplastic syndrome.
4. Patient greater than 60 years of age.
5. Women who are pregnant or nursing.
6. Patients with active hepatitis
7. Patients with severe cardiac dysfunction defined as shortening fraction \< 25%.
8. Patients with severe renal dysfunction defined as creatinine clearance \< 40 ml/mim/1.73m2.
9. Patient with severe pulmonary dysfunction with forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) 40% of predicted or 3 standard deviations (SD) below normal.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
60 Years
Study:
NCT00578903
Study Brief:
Protocol Section:
NCT00578903