Research will focus on improving and optimizing the cell culture process in a dedicated bioreactor system. The aim of the development is a closed system that can replace current cell culture practice to better guarantee the quality of the cultured…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Experiments leading to optimized cell culture.
Secondary outcome
Not applicable
Background summary
Human adult bone marrow-derived stem cells (hMSCs) are currently being
investigated as a potential treatment for various afflictions. The use of these
cells is being investigated for, among others, steroid-resistant Graft versus
Host disease and cartilage or bone defects. The current procedure for
production of these cells is very labor-intensive and, because of the open
nature of the procedure, there is a significant risk of contamination. The
development of a closed system for the safe and easy expansion of these MSCs is
important to be able to produce these cells on a larger, therapeutic scale.
Study objective
Research will focus on improving and optimizing the cell culture process in a
dedicated bioreactor system. The aim of the development is a closed system that
can replace current cell culture practice to better guarantee the quality of
the cultured cells. To this end Xpand Biotechnology examines, for example,
medium components and composition, culture substrates and environmental
parameters such as oxygen tension. Together with academic partners we will look
at different application areas and the corresponding quality controls
Study design
Patients that will receive a cementen hip prothesis will be asked to
participate. If the patient agrees, a bone marrow biopsy will be taken from the
femoral head during the hip replacement surgery.
Study burden and risks
The risks related to taking a bone marrow biopsy are negligible and, since
patients are anesthetized for surgery already, discomfort for participating
patients is minimal.
Professor Bronkhorstlaan 10, geb 48
Bilthoven 3723 MB
NL
Professor Bronkhorstlaan 10, geb 48
Bilthoven 3723 MB
NL
Listed location countries
Age
Inclusion criteria
Scheduled for total cemented hip replacement surgery
Exclusion criteria
Radiation of biopsy area
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 | NL41885.100.12 |