Primary objective is:To determine whether a single subcutaneous injection of G-CSF induces an immediate (within six hours) release of bone marrow progenitor cells in healthy volunteers.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective is:
To determine whether a single subcutaneous injection of G-CSF induces an
immediate (within six hours) release of bone marrow progenitor cells in healthy
volunteers.
Secondary outcome
nvt
Background summary
Recent findings have demonstrated that several chemotherapeutics induce an
immediate release of bone marrow progenitor endothelial cells. This release
occurs within hours after administering chemotherapy to the patient. The
clinical relevance of the release of bone marrow derived cells is currently
unclear. In preclinical tumor models perturbation of the tumor with a vascular
disrupting agent induces a similar release which coincides with rapid regrowth
of the tumor. In G-CSF receptor knock-out mice, this EPC burst didn*t occur,
indicating that G-CSF might be the primary stimulus for this release of bone
marrow derived endothelial cells.
Study objective
Primary objective is:
To determine whether a single subcutaneous injection of G-CSF induces an
immediate (within six hours) release of bone marrow progenitor cells in healthy
volunteers.
Study design
Healthy volunteers who are willing to participate and who signed informed
consent will be injected with a one time subcutaneous injection of filgrastim
of 0.03 µg or saline 0.9% (1ml). Patients will undergo a venipuncture for
sampling of approximately 13 ml of blood and in total there will be collected a
volume of 62 ml blood at 4 different timepoints. Analysis of EPC/CEC dynamics
will be performed by flowcytometry and analysis of G-CSF levels by ELISA
procedures.
Intervention
Healthy volunteers who are willing to participate and who signed informed
consent will be injected with a one time subcutaneous injection of filgrastim
of 0.03 µg or saline 0.9% (1ml). Patients will undergo a venipuncture for
sampling of approximately 9 ml of blood and in total there will be collected a
volume of 45 ml blood. Analysis of EPC/CEC dynamics will be performed by
flowcytometry and analysis of G-CSF levels by ELISA procedures.
Study burden and risks
Extent of burden for the volunteer is composed of the fact that he will undergo
a venapuncture for a iv canule once and that he will be injected once
subcutaneously with filgrastim, and the time he has to spent in the hospital,
namely six hours. The risks are the development of a hemorrage after
venapuncture.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
1.The volunteer must be >= 18 years of age
2.The volunteer must be healthy
meaning having no relevant medical history and havind no clinical signs of intercurrent infection at physical exam at start of the study
3.The volunteer mustn*t have known hypersensitivity to the to be administrated drugs (filgrastim®)
4.The patient must have given written informed consent
5. women wild child bearing potential must have a negative serum pregnancy test 48 hrs before start
Exclusion criteria
Any other condition by which the patient doesn*t meet the inclusion criteria
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004140-73-NL |
| CCMO | NL18948.041.07 |