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Normal PhysiologyNCT01123499

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

An observational study of Normal Physiology, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Normal Physiology
How many people
5 participants
Where
1 siteUnited States
Study dates
6 Oct 2016to 28 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Any healthy volunteers that are eligible to donate blood.@@@@@@

Who may be able to join

  • 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. She must continue with the effective contraception 3 months after receiving plerixafor
  • 4. The subject must be willing to allow blood cell samples to be stored.

Who cannot join

  • A subject will be ineligible to participate in this study if any of the following criteria are met:
  • The subject has a temperature > 38 degrees Celsius, or WBC > 9000/mm(3).
  • A female who is pregnant or lactating as determined by history and/or pregnancy test.
  • The subject has a history of vasculitis, uncontrolled hypertension, or symptomatic coronary artery disease, or similar disorders.
  • 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.
  • The subject lacks peripheral venous access in arm veins adequate for apheresis.
  • The subject is currently participating in other research studies.
  • The subject may be excluded at the discretion of the Principal Investigator (PI).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Collection of Peripheral Blood Stem Cells Using G-CSF and Plerixafor in Healthy Volunteers

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.
Read more

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.
Read the detailed description

Hematopoietic stem cells that have been mobilized from the bone marrow into the peripheral circulation are readily collected by apheresis, and may be used for several purposes. They are used for allogeneic and autologous transplantation and are often manipulated in various ways depending on the goal of the transplant. Gene therapy for immunodeficiencies relies on the collection of these cells.

Traditionally, mobilization has been done using granulocyte colony stimulating factor (G-CSF). However not all patients or normal donors respond to GCSF alone. Plerixafor, a recently Food and Drug Administration (FDA) approved drug, has a unique mode of action distinct from that of GCSF, but also results in mobilization of peripheral blood progenitors into the circulation, allowing their collection by standard apheresis. The quality of these cells for transduction using viral vectors in anticipation of gene therapy uses has not been thoroughly assessed, and there are theoretical considerations why vectors that use various envelopes for cell binding may be affected by the use of this CXCR4 antagonist. In order to be able to assess the transduction and engraftment of these cells in murine models, we will perform collection and mobilization on 5 healthy volunteers at the NIH Clinical Center using the FDA approved medications G-CSF and plerixafor.

Keywords
G-CSF, Plerixafor, Mozobil, Apheresis, Healthy Volunteer, Natural History, HV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01123499
Study groupRoleWhat they receive
Healthy VolunteersAny healthy volunteers that are eligible to donate blood.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apheresis

    To collect cells from normal volunteers using both G-CSF and plerixafor, to be able to use these in various research applications.

    Measured: Time of Apheresis

Secondary outcomes (1)

  1. Apheresis

    To characterize the grafts obtained from normal donors using G-CSF and plerixafor and to compare these grafts to historical grafts collected using G-CSF alone.

    Measured: 6 months after collect of cells

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2010 (estimated)
  2. Study start6 Oct 2016
  3. Primary completion27 Jan 2017
  4. Study completion28 Apr 2022

Why it stopped: Slow/Insufficient accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01123499
Sponsor's protocol ID
100095
Other IDs
10-I-0095
Status last verified
May 2021
First submitted
13 May 2010
Last updated
6 May 2022
Results posted
No

Publications

  • Levesque 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. doi: 10.1172/JCI15994.

    PubMed 12531874

  • 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. doi: 10.1182/blood-2005-02-0468. Epub 2005 May 12.

    PubMed 15890685

  • Liles WC, Broxmeyer HE, Rodger E, Wood B, Hubel 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. doi: 10.1182/blood-2003-02-0663. Epub 2003 Jul 10.

    PubMed 12855591

Questions about this trial

What is this clinical trial studying?

An observational study of Normal Physiology, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow/Insufficient accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apheresis (time frame: Time of Apheresis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01123499, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.

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