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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02636127
Enrollment
30
Registered
2015-12-21
Start date
2015-12-07
Completion date
2018-07-08
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma, Systemic

Brief 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.

Interventions

OTHERblood 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.

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
blood sample will be done for dosage of Fractalkine in the serum12 months

Secondary

MeasureTime frame
blood sample for functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC)12 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBrigitte GRANEL, MD

Assistance Publique Hôpitaux de Marseille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026