Stem Cell Mobilization Potential in Patients With Aplastic Anemia in Remission
Aplastic Anemia
About this trial
This is an interventional treatment trial for Aplastic Anemia focused on measuring Stem Cell Cryopreservation, Leukapheresis
Eligibility Criteria
INCLUSION CRITERIA History of severe AA as defined by a hypocellular bone marrow and depression of two out of three peripheral counts as indicated below: ANC less than 0.5 x 10 (9)/L; platelet count less than 20 x10 (9)/L, reticulocyte count less than 60 x 10 (9)/L. Demonstrated hematologic response to first or second course of immunosuppression or growth factors or exhibit a spontaneous remission as defined by all peripheral counts as indicated below (must be at least 3 months following the initial course of immunosupressive or growth factor therapy and must be sustained for at least 3 week) ANC greater than 1.5 x 10 (9)/L platelet count greater than 80 x10 (9)/L hemoglobin greater than 10 g/dl (not transfused) Weight > 18 kg Age greater than or equal to 2 years Able to comprehend the investigational nature of the protocol and be willing to sign an informed consent/assent. EXCLUSION CRITERIA Current diagnosis or past history of myelodysplastic syndrome, Fanconis anemia, dyskeratosis congenita or other congenital forms of aplastic anemia. Evidence of uncontrolled infection ECOG performance status of 2 or more Inadequate organ function as defined: bilirubin greater than 4.0 mg/dl and transaminases greater than than 2 x ULN. Current therapy for malignancy HIV infection Unfit to receive G-CSF and undergo apheresis (uncontrolled hypertension, currently active ischemic heart disease, unstable arrhythmia, history of chest pain, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke). Psychiatric, affective or any other disorder that would compromise ability to give informed consent Moribund or patients with concurrent hepatic, renal, cardiac, metabolic disease of such severity that death within 1-4 weeks from the initiation of the therapy is likely. An enlarged spleen by physical exam. Pregnant or lactating.
Sites / Locations
- National Heart, Lung and Blood Institute (NHLBI)