In this study the effect of a novel compound on the development of psoriasis in the humanized mouse model is investigated. In addition, the material of 3 donors wil be used to develop the mouse model further and train technicians. The focus will be…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect on the psoriatic process is tested by histology and immuno-histochemical
techniques in the transplanted biopsies. Main read-out is epidermal thickness.
Secondary outcome
Secretion of inflamatory mediators by celsl from patients.
Markers on cultured cells from psoriasis patients.
Differentiation and proliferation markers in skin.
Background summary
Psoriasis is a highly prevalent disease with great impact on the quality of
life of the patients. Current treatments are far from ideal. The development of
new compounds requiers validation in an animal model, however, many differences
exist between the skin of most animals and humans. TNO life sciences has
acquired expertise in the past years in transplanting human psoriasis skin onto
a mouse. Thereby, we are able to perform preclinical testing of compounds for
psoriasis. Non-laesional skin is transplanted onto a mouse and after
engraftment, injection with autologous T-cells synchronizes the psoriatic
process. Scientific background information can be read in Appendix 3. Since
the study involves pre-clinical testing, patients will not experience direct
benefits from participation.
Study objective
In this study the effect of a novel compound on the development of psoriasis in
the humanized mouse model is investigated. In addition, the material of 3
donors wil be used to develop the mouse model further and train technicians.
The focus will be on investigating the dynamics of the psoriatic process in the
transplanted biopsies after PBMC injections.
Study design
A pharmaceutical company has asked TNO to test a potential new therapy for
psoriasis in our humanized mouse model of psoriasis. Besides animal welfare
aproval, we also need medical ethical clearance for obtaining skin biopsies
and blood from psoriasis patients. The skin will be transplanted onto mice
after which autologous T-cells (isolated from the blood of the patients) will
be injected into the graft to synchronize development of psoriasis. As
indicated in the study protocol (Appendix 1), 4 skin punch biopsies will be
obtained from non-laesional skin as well as 5 vials of blood (ca 8ml each).
In addition, TNO wants to include 3 donros for model development.
Study burden and risks
TNO has arranged insurance for the patients participating in this study.
However, medical risks are very low. A week after obtaing skin and blood
samples, the stitches will be removed at the research center (PT&R) and a check
will take place. With the consent of the patient, the medical practitioner of
each patient will be notified about the participation.
Zernikedreef 9
Leiden 2333CK
NL
Zernikedreef 9
Leiden 2333CK
NL
Listed location countries
Age
Inclusion criteria
Psoriasis patients: Adults (m/f) with a mild to moderate form of psoriasis vulgaris (PASI score of maximal 18 and minimum BSA of 3%). Patients are allowed to use local corticosteroids or ointments to prevent dry skin (see Appendix 2).
Exclusion criteria
These patients have not received light therapy or another form of systemic treatment (methotrexate, cyclosporin A, anti-TNF treatments). Gender or age of the adults are not exclusion criteria (see Appendix 2).
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 | NL43948.028.13 |