Status:
COMPLETED
An Evaluation of Safety and Efficacy of Escalating Doses of AMD3100 to Mobilize CD34+ Cells in Healthy Volunteers
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study will determine how safely and well people can tolerate AMD3100 at larger than normal doses to mobilize CD34+ cells, (stem cells). AMD3100 is a new drug designed to mobilize stem cells for t...
Detailed Description
Peripheral blood progenitor cells (PBPC) have become the preferred source of hematopoietic stem cells for allogeneic transplantation because of technical ease of collection and shorter time required f...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Ages greater than or equal to18 years and less than or equal to 50 years
- Normal renal function: creatinine less than 1.5 mg/dl
- Normal liver function: total bilirubin less than 1.5mg/dl, ALT and AST levels must be below the laboratory's high normal value.
- Normal blood count:
- WBC 3000-10000/mm(3)
- Granulocytes greater than 1500/mm(3)
- Platelets greater than 150,000/mm(3), and
- Hemoglobin (females greater than 11.1 g/dl, males greater than 12.7 g/dl)
- Antecubital veins must be adequate for peripheral access for phlebotomy (subject must be eligible for normal blood donation)
- 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, hepatitis B and C (HBsAg, Anti-HCV), HIV and/or 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 CHD risk
- History of cerebrovascular disease, transient ischemic attack, or stroke
- Pregnant or lactating
Exclusion
Key Trial Info
Start Date :
June 14 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00322127
Start Date
June 14 2006
End Date
January 23 2015
Last Update
October 8 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892