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Protocol Details

Collection of Peripheral Blood Stem Cells Using G-CSF and Plerixafor in Normal Volunteers

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-I-0095

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

G-CSF;
Plerixafor;
Normal Volunteer;
Apheresis

Recruitment Keyword(s)

Healthy Volunteer;
HV

Condition(s)

Normal Volunteer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

- Many treatments for immune system disorders involve the use of stem cells that have been collected from blood marrow. To obtain these stem cells without surgery, individuals receive granulocyte colony-stimulating factor (G-CSF) to encourage the production of stem cells that can be collected through blood donations. However, not all patients or normal donors respond to G-CSF alone.

- Plerixafor, recently approved by the Food and Drug Administration, is different from G-CSF but also allows stem cells to be collected from donated blood. However, more research is needed on the quality and viability of the stem cells collected after using both G-CSF and plerixafor.

Objectives:

- To collect and study the blood cells produced after treatment with G-CSF and plerixafor in healthy volunteers.

Eligibility:

- Healthy volunteers between 18 and 65 years of age who are eligible to donate blood.

Design:

- Participants will be screened with a medical history, physical examination, and initial blood tests.

- At the start of the study cycle, participants will receive daily morning injections of G-CSF for 5 days. These may be given at the clinical center or by the participant after teaching, depending on the participant s preference.

- On the morning of Day 4, participants will visit the clinical center to provide a blood sample after the injection. On the evening of Day 4, participants will receive an injection of plerixafor.

- Participants will have the final injection of G-CSF on the morning of Day 5, and will provide another blood sample.

- On Day 5, participants will have apheresis to separate the stem cells from the rest of the blood. The apheresis may take up to 5 hours to complete.

- The study will end after a follow-up phone call 7 to 14 days after the apheresis procedure.

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Eligibility

INCLUSION CRITERIA:

To be eligible to participate in this study, a subject must satisfy all of the following criteria:

1. The subject must be a healthy adult aged 18-65 years, and weighing at least 50 kg.

2, The subject must have normal renal function (creatinine < 1.5 mg/dL; < 1 plus proteinuria); normal hepatic function (bilirubin < 1.5 mg/dL); normal hematologic function (WBC greater than or equal to 2500/mm(3); granulocytes greater than or equal to 1200/mm(3); platelets greater than or equal to 120,000; hematocrit greater than or equal to 38).

3. A female of childbearing potential may be entered if she is using 1 or 2 forms of effective contraception (depending on the type of contraception), and has a negative serum pregnancy test within 1 week of beginning G-CSF administration.

4. The subject must be willing to allow blood cell samples to be stored.

EXCLUSION CRITERIA:

A subject will be ineligible to participate in this study if any of the following criteria are met:

1. The subject has a temperature > 38 degrees Celsius, or WBC > 9000/mm(3).

2. A female who is pregnant or lactating as determined by history and/or pregnancy test.

3. The subject has a history of vasculitis, uncontrolled hypertension, or symptomatic coronary artery disease, or similar disorders.

4. The subject has a positive test result for any of the following: human immunodeficiency virus (HIV) I & II antibody, hepatitis C virus (HCV) antibody, hepatitis B soluble antigen (HBSAg), or the rapid plasma reagin (RPR) test for syphilis.

5. The subject lacks peripheral venous access in arm veins adequate for apheresis.

6. The subject is currently participating in other research studies.

7. The subject may be excluded at the discretion of the Principal Investigator (PI).


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Citations:

L(SqrRoot)(Copyright)vesque JP, Hendy J, Takamatsu Y, Simmons PJ, Bendall LJ. Disruption of the CXCR4/CXCL12 chemotactic interaction during hematopoietic stem cell mobilization induced by GCSF or cyclophosphamide. J Clin Invest. 2003 Jan; 111(2):187-96.

Flomenberg N, Devine SM, Dipersio JF, Liesveld JL, McCarty JM, Rowley SD, Vesole DH, Badel K, Calandra G. The use of AMD3100 plus G-CSF for autologous hematopoietic progenitor cell mobilization is superior to G-CSF alone. Blood. 2005 Sep 1;106(5):1867-74.

Liles WC, Broxmeyer HE, Rodger E, Wood B, H(SqrRoot) bel K, Cooper S, Hangoc G, Bridger GJ, Henson GW, Calandra G, Dale DC. Mobilization of hematopoietic progenitor cells in healthy volunteers by AMD3100, a CXCR4 antagonist. Blood. 2003 Oct 15; 102(8):2728-30.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Elizabeth M. Kang, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 10-CRC RM 6-3750
10 CENTER DR
BETHESDA MD 20814
(301) 402-7567
ekang@niaid.nih.gov

Sandra Maxwell, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 6-3750
10 Center Drive
Bethesda, Maryland 20892
(301) 402-1773
maxwells@niaid.nih.gov

Sandra Maxwell, R.N.
National Institutes of Health
Building 10
Room 6-3750
10 Center Drive
Bethesda, Maryland 20892
(301) 402-1773
maxwells@niaid.nih.gov

Clinical Trials Number:

NCT01123499

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