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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Scleroderma, Systemic

Treatments

Other: blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02636127
2015-37

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Systemic Sclerosis (SSc) patient
Experimental group
Description:
15 patients whose diagnosis of SSc is made according to the revised ACR/EULAR ( American College of Rheumatology ) criteria 2013 will be recruited and blood samples will be obtained
Treatment:
Other: blood samples
healthy patient
Other group
Description:
15 healthy patients will be recruited and blood samples will be obtained
Treatment:
Other: blood samples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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