In this study the material of 6 donors is used to develop and validate a humanized psoriasis model in mice. Also, the team of TNO Triskelion will be trained.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
After finalization of the validation study, the transplanted biopsies are
isolated to study the psoriatic process via histological techniques. The
primary read-out is epidermal thickness.
Secondary outcome
After finalization of the validation study, the transplanted biopsies are
isolated to study the psoriatic process via histological techniques. The
secundary read-out is proliferation and differentiation of cells in the skin.
Moreover, the activation and differentiation status of immune cells will be
determined in the blood of the donors.
Background summary
Psoriasis is a highly prevalent disease (2-3% world wide) with great impact on
the quality of life of patients. Current treatments are suboptimal. The
development of new compounds requirs validation in an animal model. However,
the skin of most animals vs humans differs significantly. TNO life sciences has
developed a humanized model for psoriasis in mice. In this model, non-laesional
skin from psoriasis patients is transplanted onto a mouse. After engraftment,
the psoriatic process is synchronized via injection of autologous immune cells.
Since the study concerns pre-clinical testing of novel drug candidates,
patients will not experience direct (therapeutic) benefit from participation.
Study objective
In this study the material of 6 donors is used to develop and validate a
humanized psoriasis model in mice. Also, the team of TNO Triskelion will be
trained.
Study design
TNO Triskelion aims to set up and validate a humanized model for psoriasis in
mice, that can be applied to analyse the efficacy of novel therapeutics for
psoriasis. Besides ethical permission for the use of laboratory animals, also
medical ethical clearance is required for isolation of skin biopsies and blood
from psoriasis patients. The skin will be transplanted onto mice after which
autologous immune cells (isolated from the blood of the patients) will be
injected into the graft to synchronize the psoriatic process. As indicated in
the study protocol
(Appendix 1), 4 skin punch biopsies of non-laesional skin as well as blood will
be obtained from each individual patient.
Study burden and risks
TNO Triskelion has signed with an insurance company for the sporiasis patients
that participate in this study (see appendix 5). Nevertheless, medical risks
are minimal. A week after isolation of skin and blood samples, the stitches
will be removed at the research center (PT&R) and a final check will take
place. With the consent of the patient, the medical practitioner of each
patient will be notified about the participation.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
Inclusion criteria
Adult Psoriasis patients, m/f, with a mild to moderate form of psoriasis vulgaris, i.e. a maximal PASI score of 18 and a minimum BSA of 3%. Patients are allowed to use local corticosteroids or ointments to prevent dry skin (see Appendix 2).
Exclusion criteria
Psoriasis patients have NOT received light therapy or another form of SYSTEMIC treatment (e.g. treatment with methotrexate, cyclosporin A or anti-TNF). Gender or age of the adult patients are no 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 | NL47830.028.14 |