Skip to main content
OpenTrials
Completed

NCT Number: NCT02636127

Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis

Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular damage, cutaneous and visceral fibrosis and a dysimmune condition.

Therapies in this disease remain insufficient and the complications resulting from organs involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved in the vascular damage of the SSc. However mechanisms at the onset of this endothelial cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune populations. The purpose of the project is to define the role displayed by cytotoxic, circulating immune populations of SSc patients in endothelial cytotoxicity as well as the role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune cytotoxic cells and the endothelium.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Scleroderma, Systemic Connective Tissue Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients affected by SSc of more than 18 years
  • Healthy patients

Exclusion criteria

  • Impossibility to take some blood
  • Current infection
  • Ongoing cancer
  • chemotherapy or a current radiotherapy
  • pregnant or breast-feeding women

Treatment and study plan

Blood Samples

Other

one blood sample will be done for dosage and role of Fractalkine in the serum.

  • Functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC): immuno mediated endothelial cytotoxicity, endothelial activation and microparticles release by the HMVEC, endothelial progenitor cells analysis and evaluation of the endothelial lysis by fluorescence release.

Primary outcomes

  1. blood sample will be done for dosage of Fractalkine in the serum

    Time frame: 12 months

Secondary outcomes

  1. blood sample for functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Dec 21, 2015
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.