Status:
COMPLETED
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-C...
Detailed Description
Peripheral blood progenitor cells (PBPC) are the most popular source of hematopoetic stem cells for allogeneic transplantation because of technical ease of collection and faster engraftment. Tradition...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy volunteers greater or equal to 18 years old, less than or equal to 60 years.
- Weight greater than 60 kg (132 pounds)
- Normal renal function: creatinine less than 1.5 mg/dl l
- Normal liver function: bilirubin less than1.5mg/dl, transaminases within normal limit
- Normal blood count: white blood cell (WBC) 3000-10000/mm3, granulocytes greater than 1500/mm3, platelets greater than 150,000/mm3, hemoglobin greater than 12.5g/dl
- Subject must be eligible for normal blood donation and fit to undergo apheresis procedure (antecubital veins must be adequate for peripheral access during apheresis)
- Ability to comprehend the investigational nature of the study and provide informed consent
- EXCLUSION CRITERIA: any of the following
- Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBaSAg, Anti-HCV), HIV and human T- Lymphocytic virus (HTLV-1)
- History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematous
- History of cancer within the past 5 years excluding basal cell or squamous cell carcinoma of the skin
- History of any hematologic disorders including thromboembolic disease
- History of cardiac disease such as uncontrolled hypertension, peripheral vascular disease, myocardial infarction, cardiac arrhythmias or related symptoms such as tachycardia, chest pain, shortness of breath which have required medical intervention or treatment or a Framingham coronary disease risk prediction score of greater than 10% 10 year coronary heart disease (CHD) risk
- History of heavy smoking with underlying pulmonary disease
- History of cerebrovascular disease, transient ischemic attack, or stroke
- Diagnosis of sickle cell anemia or sickle cell trait (to be screened by hemoglobin (Hbg) electrophoresis)
- Pregnant or lactating
- Severe psychiatric illness: mental deficiency sufficiently severe as to make informed consent impossible.
- Mobilization with G-CSF within 90 days of protocol enrollment.
Exclusion
Key Trial Info
Start Date :
June 18 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00082329
Start Date
June 18 2004
End Date
October 25 2012
Last Update
July 22 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892