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NOT YET RECRUITING
NCT07861828
NA

Exploratory Study of the Efficacy of HuMoSCs (Human Monocyte-derived Suppressor Cells) on Glandular Involvement in Sjögren's Syndrome

Sponsor: Centre Hospitalier Universitaire Dijon

View on ClinicalTrials.gov

Summary

Sjögren's syndrome is an autoimmune disease. Dry syndrome is a key feature of this condition, almost always leading to dryness of the mouth and eyes. It manifests as a decrease in the production of saliva and tears, causing discomfort for patients. This chronic dryness contributes to oral and ocular conditions. It is caused by lymphocytic infiltration of the exocrine glands, leading to their inflammation and subsequent fibrosis, which results in a decrease in fluid production by these glands. This chronic inflammation causes fatigue in the patient. Furthermore, in 30 to 60% of cases, Sjögren's syndrome may involve extra-glandular involvement, most commonly affecting the joints, but also involving the lungs, nervous system, and kidneys. Additionally, patients with thisdisease have a higher risk of developing lymphoma compared to unaffected individuals. The current treatment for Sjögren's syndrome is the same as that for dry eye syndrome; it is primarily symptomatic, involving lifestyle and dietary changes, the use of eye drops or oral lubricants, and medication to stimulate saliva production. To date, there is no medication available to treat Sjögren's syndrome and thus the cause of dry eye syndrome. In our laboratory (INSERM 1098, UMR Right), we have developed cells that suppress the immune system (immunosuppressive cells) derived from human monocytes cultured ex vivo using a patented process called HuMoSC (Human Monocyte -derived Suppressor Cells). These cells possess strong immunosuppressive capacity, already demonstrated in vitro and in vivo in mouse models. The aim of this study is to evaluate whether HuMoSCs can reduce the accumulation of immune cells and thereby decrease chronic inflammation and, in the longer term, limit the development of fibrosis (hardening with tissue destruction and scarring) in the salivary glands. Biopsy of the accessory salivary glands is already part of the diagnostic process for Sjögren's syndrome. During this biopsy, additional accessory salivary glands will be collected and sent to the laboratory for this study. These glands will be cultured in the presence of HuMoSC supernatant, and the impact of this treatment will be analyzed.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-10-10

Completion Date

2028-10-11

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

Blood sample

Collect 4 green tubes for cells and 2 tubes for serum

OTHER

Salivary gland biopsy

Sampling of two accessory salivary glands

Locations (1)

CHU Dijon Bourgogne

Dijon, France