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AUTOANTIBODIES AND SYSTEMIC SCLEROSIS

I

IRCCS Ospedale San Raffaele

Status

Not yet enrolling

Conditions

Understand Pathogenicity of SSc-specific Antibodies in SSc and the Effect of Antibody Blockade in Vitro

Treatments

Biological: Fcr blocker of autoantibodies

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

Established in vitro assays, combined with state-of-the-art multi-omics approaches and innovative in vitro experimental models, will gain insights into the mechanistic bases underlying Systemic Sclerosis (SS) pathogenesis and will dissect the consequences of treatment with Efgartigimod on functional and phenotypic cell behaviors. Healthy microvascular endothelial cells, fibroblasts and monocytes will be challenged with serum and autoantibodies prior to or upon treatment with Efgartigimod in order to assess both the prevention and the recovery capacity of the FcR blocker. The putative modulatory effect of Efgartigimod on vascular remodeling, endothelial-to-mesenchymal transition, fibroblast-to-myofibroblasts transition and monocyte behavior will be evaluated in in-vitro consolidated assays. Integrated Omics analyses will support and complement the in vitro findings by unveiling potential prognostic signatures and by identifying specific treatment-related profiles that might guide the modulation of the drug usage in order to maximize its beneficial effects.

Enrollment

6 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • positivity of autoantibodies

Exclusion criteria

  • pregnant

Trial contacts and locations

0

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Central trial contact

mARCO matucci cerinic, MD PHD

Data sourced from clinicaltrials.gov

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