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:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01383434
Eligibility Criteria:
Inclusion Criteria:
* Patients who have refractory or relapsed SAA following treatment with one or more immunosuppressive regimens.
* Age 6 months - 70 years
* Patients must meet medical criteria for myeloablative BMT
* Patients or their parents/guardians and donors must be able to sign consent forms.
* Patients must be geographically accessible and willing to participate in all stages of treatment.
Exclusion Criteria:
* Poor cardiac function: left ventricular ejection fraction \<45% as determined by MUGA or ECHO.
* Poor pulmonary function: FEV1 and FVC \<50% predicted.
* Poor renal function
* Positive leukocytotoxic crossmatch
* Women of childbearing potential who currently are pregnant (Β-HCG+) or who are not practicing adequate contraception
* Uncontrolled viral, bacterial, or fungal infections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
70 Years
Study:
NCT01383434
Study Brief:
Protocol Section:
NCT01383434