At a glance
ClinicalIndex Comparison Record- ✓Prior mobilization and collection of peripheral blood progenitor cells using G-CSF at least 60 days before enrollment
- ✓Age 18-80 years
- ✓Normal renal function (creatinine <1.5 mg/dL)
- ✓Normal liver function (total bilirubin <1.5 mg/dL, ALT 6-41 U/L, AST 9-34 U/L)
- ✕Active infection or serologic evidence of hepatitis B, hepatitis C, HIV, or HTLV-1
- ✕History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- ✕History of cancer within the past 5 years (excluding basal cell or squamous cell skin carcinoma)
- ✕History of hematologic disorders including thromboembolic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Peripheral Blood Hematopoietic Progenitor Cell Mobilization With AMD 3100 (Mozobil) in Healthy Volunteers Previously Mobilized With G-CSF
In Brief
A Phase 2 clinical trial evaluating AMD3100 (Mozobil plerixafor) for Healthy. Completed, enrolled 8 participants across 1 site.
Detailed Summary
Peripheral blood progenitor cells (PBPC) have become the preferred source of hematopoetic stem cells for allogeneic transplantation because of technical ease of collection and shorter time required for engraftment. Traditionally, granulocyte-colony stimulating factor (G-CSF) has been used to procure the peripheral blood stem cell graft. Although regimens using G-CSF usually succeed in collecting adequate numbers of PBPC from healthy donors, 5%-10% will mobilize stem cells poorly and may require multiple large volume apheresis or bone marrow harvesting. Although G-CSF is generally well tolerated in healthy donors, it may be associated with bone pain, headache, myalgia and rarely life threatening side effects like stroke, myocardial infarction and splenic rupture. AMD3100, is a bicyclam compound that inhibits the binding of stromal cell derived factor-1 (SDF-1) to its cognate receptor CXC- chemokine receptor 4 (CXCR4). CXCR4 is present on cluster of differentiation 34 (CD34)+ hematopoetic progenitor cells and its interaction with stromal cell derived factor 1 (SDF-1) plays a pivotal role in the homing of CD34+ cells in the bone marrow. Inhibition of the CXCR4-SDF1 axis by AMD3100 releases CD34+ cells into the circulation, which can then be collected easily by apheresis. Recently, a published report demonstrated that large numbers of CD34+ cells were rapidly mobilized in healthy volunteers following a single subcutaneous injection of AMD3100. Remarkably, the number of CD34+ cells collected by apheresis following a single injection of AMD3100 was comparable to the number of CD34+ cells collected from historical controls receiving 5 days of G-CSF prior to stem cell mobilization. In this study we will collect PBPCs following a single subcutaneous injection of AMD3100 from healthy donors who have previously had PBPC collected using standard G-CSF mobilization. The AMD3100 mobilized cells, G-CSF mobilized cells, and circulating cells prior to both AMD3100 and G-CSF mobilization will be analyzed in terms of cellular content and function of lymphocytes, natural killer (NK) cells, and antigen presenting cells. AMD3100 mobilized PBPC will be collected for the purpose of research studies and will not be used for therapeutic purposes.
Study Details
Timeline
Interventions
AMD 3100 (Mozobil plerixafor)mobilized peripheral blood hematopoietic progenitor cells from healthy volunteers will be characterized by cellular content and immunological properties.