G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Condition: Healthy
Intervention: AMD 3100 (Mozobil plerixafor); Granulocyte colony-stimulating factor (G-CSF)
Intervention description: Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.; Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.
Intervention MeSH terms: Plerixafor; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hematopoietic Stem Cells; PBSC's; Mobilization; Alloreactivity; T Cell Polarization; Dendritic Cells; CXCR4; Plerixafor; Healthy Volunteer (HV)

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-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell
      donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation
      for collection for transplantation. Although a sufficient quantity of cells usually can be
      collected with G-CSF treatment, some donors do not respond well and may require multiple
      apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used
      together with a drug called AMD3100 may be more effective in mobilizing stem cells for
      collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem
      cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers
      within a few hours.

      Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.
    

Eligibility criteria:

        -  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.