G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers

NCT00082329 | Completed Phase 2 Results

• 2 other identifiers: 04017904-H-0179
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) 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 G-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.

Conditions

Healthy

Keywords

Hematopoietic Stem Cells; PBSC's; Mobilization; Alloreactivity; T Cell Polarization; Dendritic Cells; CXCR4; Plerixafor; Healthy Volunteer (HV)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF.

  Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis. We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization. Successful treatment responders is defined by completing study treatment with cell mobilization and cell collection. Non-responders is defined by having completed the study treatment and having cell mobilization without cell collection.

  Day 1 (cells are counted 24 hours after AMD3100)

Secondary Outcomes (2)

• Average Fold Change From Baseline of Mobilized Cells Following G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers

  Day 7

• Number of Participants With Increased the Levels of Circulating Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis.

  Day 7

Study Arms (1)

G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers

EXPERIMENTAL

Participants received subcutaneous injection of G-CSF (10 mcg/kg/day) for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.

Drug: AMD 3100 (Mozobil plerixafor); Drug: Granulocyte colony-stimulating factor (G-CSF)

Interventions

AMD 3100 (Mozobil plerixafor) DRUG

Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.

Also known as: AMD 3100

G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers

Granulocyte colony-stimulating factor (G-CSF) DRUG

Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.

Also known as: G-CSF

G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers greater or equal to 18 years old, less than or equal to 60 years.
• Weight greater than 60 kg (132 pounds)
• 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: white blood cell (WBC) 3000-10000/mm3, granulocytes greater than 1500/mm3, platelets greater than 150,000/mm3, hemoglobin greater than 12.5g/dl
• Subject must be eligible for normal blood donation and fit to undergo apheresis procedure (antecubital veins must be adequate for peripheral access during apheresis)
• Ability to comprehend the investigational nature of the study and provide informed consent

You may not qualify if:

• Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBaSAg, Anti-HCV), HIV and human T- Lymphocytic virus (HTLV-1)
• 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 including thromboembolic disease
• History of cardiac disease such as uncontrolled hypertension, peripheral vascular disease, myocardial infarction, cardiac arrhythmias or related symptoms such as tachycardia, chest pain, shortness of breath which have required medical intervention or treatment or a Framingham coronary disease risk prediction score of greater than 10% 10 year coronary heart disease (CHD) risk
• History of heavy smoking with underlying pulmonary disease
• History of cerebrovascular disease, transient ischemic attack, or stroke
• Diagnosis of sickle cell anemia or sickle cell trait (to be screened by hemoglobin (Hbg) electrophoresis)
• Pregnant or lactating
• Severe psychiatric illness: mental deficiency sufficiently severe as to make informed consent impossible.
• Mobilization with G-CSF within 90 days of protocol enrollment.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Gyger M, Stuart RK, Perreault C. Immunobiology of allogeneic peripheral blood mononuclear cells mobilized with granulocyte-colony stimulating factor. Bone Marrow Transplant. 2000 Jul;26(1):1-16. doi: 10.1038/sj.bmt.1702464.

  PMID: 10918400 BACKGROUND

• Bellucci R, De Propris MS, Buccisano F, Lisci A, Leone G, Tabilio A, de Fabritiis P. 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. doi: 10.1038/sj.bmt.1701522.

  PMID: 10037043 BACKGROUND

• 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 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Interventions

plerixafor; Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Richard Childs
• Organization: NHLBI NIH

childsr@nhlbi.nih.gov

301-594-8008

Study Officials

• Richard W Childs, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2004
• First Posted: May 6, 2004
• Study Start: June 18, 2004
• Primary Completion: October 25, 2012
• Study Completion: October 25, 2012
• Last Updated: July 22, 2021
• Results First Posted: May 2, 2014

Record last verified: 2021-05

Locations

US (1)