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

Scleroderma, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636127
• Other study ID #: 2015-37
• Status: Completed
• Phase: N/A
• Start date: December 7, 2015
• Est. completion date: July 8, 2018

Study information

• Verified date: September 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 8, 2018
• Est. primary completion date: July 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

Other:
• blood samples
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.

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood sample will be done for dosage of Fractalkine in the serum		12 months
Secondary	blood sample for functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC)		12 months