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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bernard BONNOTTE
- Phone Number: +33 03 80 29 34 32
- Email: bernard.bonnotte@chu-dijon.fr
Study Locations
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-
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Dijon, France, 21000
- CHU Dijon Bourgogne
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Contact:
- Bernard BONNOTTE
- Phone Number: +33 03 80 29 34 32
- Email: bernard.bonnotte@chu-dijon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with Sjögren's syndrome
|
Collect 4 green tubes for cells and 2 tubes for serum Sampling of two accessory salivary glands |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of the various subclasses of lymphocytes and macrophages
Time Frame: 24 months
|
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
|
|
Concentrations of inflammatory and anti-inflammatory cytokines in the culture supernatants of accessory salivary glands cultured with or without HuMoSC supernatant.
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Immune System Diseases
- Eye Diseases
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Lacrimal Apparatus Diseases
- Skin and Connective Tissue Diseases
- Sjogren's Syndrome
- Autoimmune Diseases
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- BONNOTTE 2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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