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

NCT01123499 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2022-05-06

No results posted yet for this study

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 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.

Conditions

  • Normal Physiology

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Elizabeth M Kang, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-06
Primary Completion
2017-01-27
Completion
2022-04-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123499 on ClinicalTrials.gov