In this study the material of 20 donors is used to validate the humanized mouse model for psoriasis with clinically relevant compounds.
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.
Also, serum is collected on day 21, in which e.g. cytokine measurements can be
performed to evaluate the systemic immune reaction.
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 requires validation in an animal model. However,
the skin of most animals vs humans differs significantly.
TNO Triskelion 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 20 donors is used to validate the humanized mouse
model for psoriasis with clinically relevant compounds.
Study design
TNO Triskelion aims to validate the humanized mouse model for psoriasis with
clinically relevant compounds. Subsequently, the model 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 | NL49057.028.14 |