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 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT00578266
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of SAA based on bone marrow aspirate and biopsy results. Failure to respond to immunosuppressive therapy and/or lack of an HLA identical family member.
* A 10/10 or 9/10 HLA matched unrelated donor or a 9/10 matched related donor available after high resolution typing.
Exclusion Criteria:
* Patients with Aplastic anemia and active infection must be treated to maximally resolve this problem before beginning the conditioning regimen.
* HIV seropositive patients
* Patients who have clonal cytogenetic abnormalities or a myelodysplastic syndrome.
* Patient greater than 60 years of age.
* Women who are pregnant or nursing.
* Patients with active hepatitis
* Patients with severe cardiac dysfunction defined as shortening fraction \<25%.
* Patients with severe renal dysfunction defined as creatinine clearance \<40ml/mim/1.73m2.
* Patient with severe pulmonary dysfunction with FEV1, FVC and DLCO 40% of predicted or 3 SD below normal.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
60 Years
Study:
NCT00578266
Study Brief:
Protocol Section:
NCT00578266