Protocol Number: 04-H-0179

Title:

Peripheral Blood Hematopoietic Progenitor Cell Mobilization Using Granulocyte Colony Stimulating Factor (G-CSF) Combined With AMD3100 in Healthy Volunteers

Number:

04-H-0179

Summary:

This 12-day study will test whether the combination of C-CSF (granulocyte-colony stimulating factor) and AMD3100 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 C-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. Candidates are screened with a medical history, physical examination, blood and urine tests, and electrocardiogram (EKG).

Participants undergo the following tests and procedures:

Day 1:

- Blood draw for clinical monitoring and for research studies

- Baseline abdominal ultrasound to measure spleen size

- C-CSF injection under the skin

Days 2 and 3:

- G-CSF injections under the skin

Day 4:

- G-CSF injection

- Blood draw for clinical monitoring and for research studies

- Abdominal ultrasound to monitor for changes in spleen size

- AMD3100 injection in the abdomen, arm, or thigh

Day 5:

- G-CSF injection

- Blood draw for clinical monitoring and for research studies

- Apheresis to collect stem cells. For this procedure, a catheter (plastic tube) is placed in a vein in each arm. Blood is withdrawn from one vein and circulated through a cell separator machine, which collects and saves stem cells and lymphocytes (a type of white blood cell) and returns the rest of the blood to the subject through the catheter in the vein in the other arm. The collected stem cells are not given to a patient, but are examined in the laboratory to see if they are suitable for transplant.

- Blood draw to monitor for side effects

- EKG

- Abdominal ultrasound to monitor for changes in spleen size

Days 10 through 12:

- Telephone follow-up for review of symptoms

- Blood draw to monitor for treatment side effects

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Hematopoietic Stem Cells

PBSC's

Mobilization

Alloreactivity

T Cell Polarization

Dendritic Cells

CXCR4

Plerixafor

Recruitment Keyword(s):

Healthy Volunteer

HV

Condition(s):

Healthy

Investigational Drug(s):

AMD3100

Investigational Device(s):

None

Interventions:

Drug: AMD3100

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Gyger M, Immunobiology of allogeneic peripheral blood mononuclear cells mobilized with granulocyte-colony stimulating factor. Bone Marrow Transplant. 2000 Jul;26(1):1-16.

Bellucci R, Modulation of VLA-4 and L-selectin expression on normal CD34+ cells during mobilization with G-CSF. Bone Marrow Transplant. 1999 Jan;23(1):1-8.

Mohle 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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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