- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07861828
Exploratory Study of the Efficacy of HuMoSCs (Human Monocyte-derived Suppressor Cells) on Glandular Involvement in Sjögren's Syndrome (Immuno-DRYve)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Bernard BONNOTTE
- Telefonnummer: +33 03 80 29 34 32
- E-mail: bernard.bonnotte@chu-dijon.fr
Studiesteder
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Dijon, Frankrig, 21000
- CHU Dijon Bourgogne
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Kontakt:
- Bernard BONNOTTE
- Telefonnummer: +33 03 80 29 34 32
- E-mail: bernard.bonnotte@chu-dijon.fr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- A person who has given verbal consent
- A person exhibiting symptoms consistent with Sjögren's syndrome who is scheduled to undergo diagnostic testing
Exclusion Criteria:
- A person who is not enrolled in or eligible for a social security program
- A person subject to a legal guardianship order (curatorship, guardianship)
- A person subject to a court-ordered protective measure
- Pregnant women, women in labor, or breastfeeding women
- An adult who is legally incapacitated or unable to give consent
- A minor
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Patients with Sjögren's syndrome
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Collect 4 green tubes for cells and 2 tubes for serum Sampling of two accessory salivary glands |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of the various subclasses of lymphocytes and macrophages
Tidsramme: 24 months
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To identify, using immunohistochemistry and cytokine analysis, a reduction in inflammatory infiltration (lymphocytes and macrophages) of the accessory salivary glands in the presence of HuMoSC supernatant. |
24 months
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Concentrations of inflammatory and anti-inflammatory cytokines in the culture supernatants of accessory salivary glands cultured with or without HuMoSC supernatant.
Tidsramme: 24 months
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24 months
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Muskuloskeletale sygdomme
- Mundsygdomme
- Stomatognatiske sygdomme
- Gigt
- Ledsygdomme
- Reumatiske sygdomme
- Bindevævssygdomme
- Sygdomme i immunsystemet
- Øjensygdomme
- Gigt, reumatoid
- Xerostomi
- Spytkirtelsygdomme
- Syndromer med tørre øjne
- Sygdomme i tåreapparatet
- Hud- og bindevævssygdomme
- Sjøgrens syndrom
- Autoimmune sygdomme
- Undersøgelsesteknikker
- Håndtering af eksemplar
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Punkteringer
- Kirurgiske procedurer, operative
- Blodprøveopsamling
Andre undersøgelses-id-numre
- BONNOTTE 2026
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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