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NCT00039650 · ClinicalTrials.gov registry record
Pilot Study: Effects of G-CSF on T Cell Function
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 15
- Enrollment target
NCT00039650 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 15 participants.
The verdict
NCT00039650 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
This study will evaluate changes in T cells-infection-fighting white blood cells of the immune system-in people given a drug called G-CSF before donating stem cells (immature bone marrow cells) for transplantation. Originally, bone marrow cells were obtained using a needle inserted into the hipbone of the donor. However, when it was discovered that immature bone marrow cells also circulate in the blood, scientists began to develop techniques to collect quantities of these cells from the blood instead of the bone. G-CSF is a blood cell growth factor that pushes stem cells from the bone marrow into the bloodstream. Stem cell donors are given this drug 5 to 6 days before donation to make more cells available in the circulating blood for collection. Stem cell transplantation requires careful regulation of immune cell function to allow the donated stem cells to grow in the transplant recipient, to prevent the transplanted cells from damaging the recipient, and to allow the recipient's new immune system to develop normally so it can fight infections. Studies comparing the outcome of patients transplanted with bone marrow cells with those transplanted with stem cells suggest that the G-CSF given to stem cell donors affects the function of T cells in transplant recipients. This study will collect white cells containing T cells before and after G-CSF administration to determine the effects of the drug on both T cells and stem cells. Healthy normal volunteers 18 years of age and older who meet the health criteria for donating blood may participate in this study. Pregnant and breastfeeding women are not eligible. Participants will undergo the following procedures: * Blood sample collection (15 milliliters, or 3 teaspoons) to measure blood cell counts * Electrocardiogram to assess heart function * Apheresis to donate white blood cells. Participants will undergo two apheresis procedures-once before receiving G-CSF and a second time immediately after finishing the 5-day cours
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2002-05 |
| Est. Completion | 2004-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00039650
The ClinicalTrials.gov registry entry for NCT00039650 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00039650 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00039650 about?
NCT00039650 is a clinical study titled "Pilot Study: Effects of G-CSF on T Cell Function". This study will evaluate changes in T cells-infection-fighting white blood cells of the immune system-in people given a drug called G-CSF before donating stem cells (immature bone marrow cells) for transplantation. Originally, bone marrow cells were obtained using a needle inserted into the hipbone ...
What is the current status of trial NCT00039650?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2002-05. Estimated completion is 2004-03.
Who is sponsoring clinical trial NCT00039650?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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