Since the approval of this protocol, 17 patients have been evaluated for idiopathic anaphylaxis. All patients were admitted to the inpatient unit and underwent a bone marrow procedure for aspirates and biopsies in an attempt to elucidate the etiology and evaluate the pathogenesis of their disease. Patients also had research blood drawn along with routine labs. In collaboration with the NIH Clinical Center's myeloid core facility, we were able to assess all the patient bone marrow aspirates and biopsies obtained based on the current WHO criteria to rule out the diagnosis of systemic mastocytosis. Mast cells derived from peripheral mononuclear cells were cultured for mast cell growth and comparison studies with healthy volunteers (separate protocol 96-I-0129). There were no adverse events associated with any procedure. No subjects have yet enrolled in the randomized treatment protocol with omalizumab (09-I-0129). We are continuing to screen patients to rule out mastocytosis on the idiopathic anaphylaxis protocol. Thus far, the patients enrolled either have been diagnosed with mastoctyosis (exclusion criteria) or no longer meet frequency data points needed to qualify for the treatment protocol.
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