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Home > "A" Clinical Trials Conditions > AMD3100 to Mobilize Stem Cells for Donation  AMD3100 to Mobilize Stem Cells for Donation
AMD3100 to Mobilize Stem Cells for Donation
For Condition:
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: This study will evaluate the safety and effectiveness of a new drug, AMD3100, for mobilizing, or "pushing" stem cells from the bone marrow into the bloodstream for collection. Traditionally, a drug called G-CSF has been given to stem cell donors for this purpose. However, preliminary studies show that a single injection of AMD3100 can move adequate numbers of stem cells into the bloodstream within a few hours, as opposed to 5 or 6 days of injections required using G-CSF. Also, AMD3100 has been well tolerated and has not caused the flu-like symptoms or bone pain that are sometimes associated with G-CSF. This study will test whether AMD3100 can make the stem cell donation process easier, safer, less unpleasant, and less time-consuming than that experienced with G-CSF. The collected cells will also be studied to see if they are suitable for transplant, but will not be given to patients. Donors between 18 and 80 years of age who have provided stem cells for a relative who had stem cell transplant at the NIH may be eligible for this study. Participants undergo the following tests and procedures: Day 1 The day before the AMD3100 injection, participants have their medical history taken and have a physical examination, electrocardiogram (EKG), and blood tests. Day 2 Participants receive one injection of AMD3100 in the abdomen, arm, or thigh. Six hours after the injection, they undergo apheresis to collect the stem cells. For this procedure, blood is collected through a needle in an arm vein, similar to donating blood. The blood flows from the vein through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The stem cells and white cells are removed, and the rest of the blood (red cells, plasma and platelets) is returned to the donor through a needle in the other arm. After the apheresis procedure, 5 tablespoons of blood are drawn to check for side effects and an EKG is done. Day 7 Participants are contacted 1 week after the apheresis to report any symptoms they may have experienced. Another 5 tablespoons of blood are drawn to check for side effects. This sample may be collected at the donor's primary care physician's office and shipped to NIH or it may be collected at a follow-up visit to the NIH Clinical Center.
Details: 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 CXCR4. CXCR4 is present on CD34+ hematopoetic progenitor cells and its interaction with 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. Although the study population is relatively small, side-effects to this agent have been mild and transient with no serious complications having been reported. The ability to collect a large quantity of PBPC with a single injection of this drug makes this an attractive agent for mobilizing donors of allogeneic PBPC. However, the immunologic profiles of AMD3100 mobilized cells, in terms of lymphocyte content (T cell, B cell, NK cell, immuno-regulatory T cell), T cell polarization status (TH1 versus TH2), status of antigen presenting cells (DC1 versus DC2), alloreactive potential, and preservation of reactivity to infectious agents (e.g. EBV, CMV) are unknown. Consequently, whether AMD3100 mobilized PBPC would be suitable for use as an allograft is uncertain. 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, 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.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Mobilization and collection of PBPC using G-CSF at least 60 days prior to protocol enrollment. Ages greater than or equal to 18 years and less than or equal to 80 years 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: WBC 3000-10000/mm3, granulocytes greater than 1500/mm3, platelets greater than150,000/mm3, hemoglobin greater than 12.5g/dl No history of chest pain, uncontrolled hypertension, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke No active infection or history of recurrent infection [positive test for syphilis (RPR), hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV and HTLV-1 within 3 months of protocol enrollment] Subject must be eligible for normal blood donation and fit to undergo apheresis procedure (Antecubital veins must be adequate for peripheral access during apheresis) Female subjects of childbearing age should have a negative serum pregnancy test within one week of beginning AMD3100 administration. Female subjects should not be lactating. Ability to comprehend the investigational nature of the study and provide informed consent EXCLUSION CRITERIA: any of the following Age less than 18 years or more than 80 years Pregnant or lactating Severe psychiatric illness: mental deficiency sufficiently severe as to make informed consent impossible. 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 History of cardiac disease or related symptoms such as tachycardia, chest pain, shortness of breath, history of cerebrovascular disease
Total Enrollment: 25
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040078; 04-H-0078
Study Start Date: January 7, 2004
Record last reviewed: December 19, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075335
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AMD3100 to Mobilize Stem Cells for Donation
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