Sjogren's SyndromeImmuno-DRYveNCT07861828
Exploratory Study of the Efficacy of HuMoSCs (Human Monocyte-derived Suppressor Cells) on Glandular Involvement in Sjögren's Syndrome
A study testing Blood sample and Salivary gland biopsy in people with Sjogren's Syndrome and Autoimmune Diseases, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome, Autoimmune Diseases
- What is being tested?
- Blood sample and Salivary gland biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2026to 11 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A person who has given verbal consent
- A person exhibiting symptoms consistent with Sjögren's syndrome who is scheduled to undergo diagnostic testing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Dijon Bourgogne
Dijon, 21000
Bernard BONNOTTE, 03 80 29 34 32 ext. +33, bernard.bonnotte@chu-dijon.fr
About this study
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.
Read more
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.
- Conditions
- Sjogren's Syndrome, Autoimmune Diseases
- Being tested
- Blood sample, Salivary gland biopsy
- Medical subject headings
- Sjogren's Syndrome, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Collect 4 green tubes for cells and 2 tubes for serum
Salivary gland biopsyOther
Sampling of two accessory salivary glands
| Study group | Role | What they receive |
|---|---|---|
| Patients with Sjögren's syndrome | Experimental | Not described Receives: Biological: Blood sample; Other: Salivary gland biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the various subclasses of lymphocytes and macrophages
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.
Measured: 24 months
Concentrations of inflammatory and anti-inflammatory cytokines in the culture supernatants of accessory salivary glands cultured with or without HuMoSC supernatant.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion11 Oct 2028 (estimated)
- Study completion11 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861828
- Sponsor's protocol ID
- BONNOTTE 2026
- Acronym
- Immuno-DRYve
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Efficacy of HuMoSCs (Human Monocyte-derived Suppressor Cells) on Glandular Involvement in Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT07861828
- Acronym / sponsor ID
- Immuno-DRYve / BONNOTTE 2026
- Conditions
- Sjogren's Syndrome, Autoimmune Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 11 Oct 2028 (estimated)
- Study completion
- 11 Oct 2028 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Sjögren's syndrome | Experimental | Biological: Blood sample, Other: Salivary gland biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A person who has given verbal consent
- A person exhibiting symptoms consistent with Sjögren's syndrome who is scheduled to undergo diagnostic testing
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleCollect 4 green tubes for cells and 2 tubes for serum | Biological | Patients with Sjögren's syndrome |
| Salivary gland biopsySampling of two accessory salivary glands | Other | Patients with Sjögren's syndrome |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and Salivary gland biopsy in people with Sjogren's Syndrome and Autoimmune Diseases, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard BONNOTTE (03 80 29 34 32 ext. +33, bernard.bonnotte@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the various subclasses of lymphocytes and macrophages (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.