A Phase I/II Trial of Recombinant-Methionyl Human Stem Cell Factor (SCF) in Adult Patients With Sickling Disorders
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|ClinicalTrials.gov Identifier: NCT00005783|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Hemoglobin SC Disease Sickle Cell Anemia||Drug: Recombinant-methionyl human stem cell factor||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Official Title:||A Phase I/II Trial of Recombinant-Methionyl Human Stem Cell Factor (SCF) in Adult Patients With Sickling Disorders|
|Study Start Date :||March 2000|
|Study Completion Date :||October 2000|
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005783
|United States, Maryland|
|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Bethesda, Maryland, United States, 20892|
|Other Study ID Numbers:||
|First Posted:||December 10, 2002 Key Record Dates|
|Last Update Posted:||March 4, 2008|
|Last Verified:||February 2000|
Hematopoietic Growth Factor
Peripheral Blood CD34 Cells
Sickle Cell Anemia
Sickle Cell Disease
Sickle Cell Disorder
Anemia, Sickle Cell
Hemoglobin SC Disease
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn