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This study examined recombinant-methionyl human stem cell factor (SCF) in adult patients with sickling disorders. Patients aged 18 and over with Hb SS, S-beta-thalassemia, SD, or SO-Arab disease who met certain criteria could take part. The study was carried out in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
INCLUSION CRITERIA: Patients with Hb SS, Sbeta-thal, SD, or SO-Arab Age greater than or equal to 18 years. Patient must have had a previous neurologic event (either symptomatic or found by imaging alone). More than one painful crises per year for the last 2 years, each requiring hospitalization. A previous acute chest syndrome. Evidence of renal damage but with a creatinine clearance of greater than 50 percent of normal. Red cell alloimmunization. Bilateral retinopathy. Osteonecrosis of multiple bones. Unilateral or bilateral leg ulcers. Patients who have failed a course of hydroxyurea or who have declined to take hydroxyurea. Able to give informed consent. No active sickle cell crises or acute chest syndrome. No active uncontrolled infection. No hydroxyurea, erythropoietin, and/or arginine butyrate therapy in the previous month. No patients receiving hypertransfusion therapy. No current treatment (or within 2 weeks) with hematopoietic growth factors. No allergy to E. coli derived products. No history of seasonal or recurrent asthma within the 5 preceding years. No asthmatic symptoms (e.g. wheezing) related to a current respiratory tract infection. No other significant IgE-mediated hypersensitivities (including but not limited to allergic rhinitis, allergic eczema, anaphylactic reactions, congenital or acquired angioedema, and urticaria,). An isolated episode of urticaria occurring within the 5 years is not a contraindication. Patients with drug allergies manifested solely by rash are not excluded. No concurrent use of beta-adrenergic blocking agents. No concurrent use of monoamine oxidase inhibitors. No significant comorbid conditions including uncontrolled hypertension, congestive heart failure(greater NY class II), poorly controlled diabetes mellitus, and significant coronary artery disease with recent myocardial infarction or angioplasty (within the previous 6 months). No pregnancy, breast feeding, and unwillingness to use contraception. No concurrent use of other investigational products.