This protocol serves to establish a formal procedure to allow collection of blood samples from healthy volunteers within the Department of Internal Medicine to be used for development and/or optimization of transplantation-related in vitro assays
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
orgaantransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Collection of blood
Secondary outcome
n.a.
Background summary
Research of the Nephrology and Transplantation laboratory within the Department
of Internal Medicine of the Erasmus MC focuses on studying the immune system of
the kidney transplantation recipient towards the kidney donor. This immune
reactivity can be mimicked in vitro by using peripheral blood mononuclear cells
(PBMCs) of both the recipient and donor. PBMCs are obtained from peripheral
blood, collected in tubes containing an anticoagulant (heparin, EDTA or
citrate).
For development and optimization of transplantation-related in vitro research,
PBMCs of healthy volunteers are needed in order to spare and make optimal use
of PBMCs obtained from recipients and their kidney donors.
Peripheral blood obtained Sanquin Blood Supply (SBS) cannot easily be used for
this purpose as many experiments require a minimum time period between blood
collection and its use for the in vitro experiment. Due to the release
criteria, the blood from SBS is usually 24-48 hours old when it is released.
This period compromises functionality of many different populations within
PBMCs.
Many employees within the Department of Internal Medicine are eager to donate
blood to thereby contribute to development and optimization of
transplantation-related assays. However, some fear or dislike venapuncture and
these individuals are and will never be pressurized to donate blood.
Study objective
This protocol serves to establish a formal procedure to allow collection of
blood samples from healthy volunteers within the Department of Internal
Medicine to be used for development and/or optimization of
transplantation-related in vitro assays
Study design
Collection of a maximum number of five tubes of blood (max 50 ml) is the only
procedure in this study. Blood products are exclusively used for in vitro
studies, in particular development of new and optimization of current
transplantation-related assays.
Briefly, using freshly drawn blood/isolated cells of employees 1) new assays
and techniques will be developed before applying them to blood (cells) of
kidney transplant recipients and 2) cellular immune reactivity of kidney
transplant recipients will be compared to that of healthy individuals
(employees).
The tests will thus be performed using fresh (not frozen) cells from blood. Any
cells not used for the test will be frozen.
Study burden and risks
The burden for the volunteer is minimal and we consider the risk of
venapuncture in healthy volunteers as negligible and might comprise of a bruise
and pain symptoms at the site of puncture. The venapuncture will take place by
a qualified person in a separate room optimally equipped for venapunctures.
Participation does not compose of a direct advantage for the volunteer but
contributes to facilitating development and optimization of new
transplantation-related assays.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
persons 21 years of age and older, those that are a member or student within the Department of Internal Medicine and have no signs of a disease
Exclusion criteria
persons who are directly dependent on the workgroup leader for whom the research is required (students and technicians working directly for the PI are thus excluded) and those having signs of a disease.
Design
Recruitment
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 |
|---|---|
| CCMO | NL66443.078.18 |