Protocol Number: 04-H-0078

Title:

Peripheral Blood Hematopoietic Progenitor Cell Mobilization with AMD3100 in Healthy Volunteers Previously Mobilized with G-CSF

Number:

04-H-0078

Summary:

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.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility 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

Special Instructions: Currently Not Provided

Keywords:

Hematopoietic Stem Cells

PBSC's

Mobilization

Alloreactivity

Recruitment Keywords:

Healthy Volunteer

HV

Conditions:

Healthy

Blood Component Removal

Investigational Drug(s):

AMD3100

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Mohle R, Murea S, Kirsch M, Haas R.

Differential expression of L-selectin, VLA-4, and LFA-1 on CD34+ progenitor cells from bone marrow and peripheral blood during G-CSF-enhanced recovery.

Exp Hematol. 1995 Dec;23(14):1535-42.

PMID: 8542944

Mohle R, Haas R, Hunstein W.

Expression of adhesion molecules and c-kit on CD34+ hematopoietic progenitor cells: comparison of cytokine-mobilized blood stem cells with normal bone marrow

and peripheral blood.

J Hematother. 1993 Winter;2(4):483-9.

PMID: 7522108

Petit I, Szyper-Kravitz M, Nagler A, Lahav M, Peled A, Habler L, Ponomaryov T, Taichman RS, Arenzana-Seisdedos F, Fujii N, Sandbank J, Zipori D, Lapidot T.

G-CSF induces stem cell mobilization by decreasing bone marrow SDF-1 and up-regulating CXCR4.

Nat Immunol. 2002 Jul;3(7):687-94. Epub 2002 Jun 17. Erratum in: Nat Immunol 2002 Aug;3(8):787.

PMID: 12068293

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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