- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005783
A Phase I/II Trial of Recombinant-Methionyl Human Stem Cell Factor (SCF) in Adult Patients With Sickling Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000087
- 00-DK-0087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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