Sjorgren's SyndromePhase 1/2ASSIXNCT06805448
Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögren's Disease
A Phase 1/2 study testing MSC in people with Sjorgren's Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Living with dry mouth significantly impacts daily life, causing constant discomfort. It makes it harder to talk, eat solid food (increasing the risk of malnutrition), swallow, and sleep well. It also raises the risk of tooth decay. One common cause of dry mouth is Sjögren's Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjorgren's Syndrome
- What is being tested?
- MSC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Jan 2025to Dec 2025
- Phase
- Phase 1/2
- 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
- Patients diagnosed with SS according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) classification criteria for primary SjD (2)
- Age equal or above 18 years
- Persistent xerostomia for at least 3 months
- Unstimulated whole saliva flow rate (UWS) of minimum 0.05 ml/min and maximum 3.0 ml/min
- Capable and willing to receive proper information and to give written informed consent.
Who cannot join
- Current intake of xerogenic medications such as anticholinergics, tricyclic antidepressants, opioids, and certain antihypertensive agents (23)
- Presence of any other diseases of the salivary glands, e.g. xerostomia due to radiation
- Previous submandibular gland surgery
- Previous treatment with any type of stem cells in the salivary glands
- Pregnancy or planned pregnancy within the 12 months study period
- Breastfeeding
Show all 9Show fewer
- Tobacco smoking within the previous 6 months from screening visit
- Have a current alcohol abuse (consumption must not exceed 10 units per week (Danish National board health alcohol guidelines (24))
- Any other disease/condition judged by the investigator to be grounds for exclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Joachim Hansen, M.D PhD-fellow, +4523312552, joachim.hansen.01@regionh.dk
Joachim Hansen, M.D PhD-fellow
About this study
Official title: Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögrens Disease
Living with dry mouth significantly impacts daily life, causing constant discomfort. It makes it harder to talk, eat solid food (increasing the risk of malnutrition), swallow, and sleep well. It also raises the risk of tooth decay. One common cause of dry mouth is Sjögren's Syndrome.
Sjögren's Syndrome is a common chronic autoimmune disease. In this disease, the immune system attacks the body's own saliva glands, reducing saliva production and leading to severe dry mouth and its associated symptoms.
Read more
Current treatments for dry mouth are temporary and only last a short time (from a few minutes to a few hours). Therefore, new treatment options are needed.
Research has shown that mesenchymal stem cells can be used to treat dry mouth with promising results. These stem cells can be injected into a vein or directly into the saliva glands. Although the exact mechanism is not fully understood, studies suggest that stem cells can positively affect the immune system, reduce inflammation, regenerate tissue, and reverse scarring.
This research group has been studying stem cell treatment for dry mouth for over 10 years and is internationally recognized. The group have conducted three studies where we injected stem cells into the saliva glands of patients with dry mouth due to radiation therapy for head or neck cancer. Results showed a 30%-50% increase in saliva production and a significant reduction in dry mouth symptoms. No studies have yet investigated injecting stem cells into the saliva glands of patients with dry mouth due to Sjögren's Syndrome. One study did inject stem cells into tear glands with promising results. Therefore, this study aim to investigate injecting stem cells into the saliva glands of patients with dry mouth due to Sjögren's Syndrome.
For this study, mesenchymal stem cells harvested from the fat tissue of healthy adult donors is used. This type of stem cell is better at reversing scarring and forming new blood vessels. The procedure is quick and has few side effects, and donors benefit from the fat removal. The fat is typically taken from the abdominal area. Donors are tested for various diseases to ensure they are healthy. Previous studies have shown that the treatment is safe with only a few temporary side effects.
The hypothesis is that injecting stem cells into the saliva glands of patients with dry mouth due to Sjögren's Syndrome will improve saliva production and reduce dry mouth symptoms. The study aims to determine if this treatment increases saliva production and reduces symptoms caused by dry mouth.
To test these hypotheses, the study will include:
- The treatment itself with either stem cells or a placebo (sterile saline).
- Multiple saliva tests to measure saliva production.
- Saliva samples stored for later analysis to see if the saliva's ability to protect teeth and aid digestion changes after stem cell treatment.
- A blood test to examine the immune system's response to the stem cell treatment.
- A clinical examination to see if the stem cell treatment affects Sjögren's Syndrome symptoms elsewhere in the body.
- Questionnaires to assess participants' perceptions of changes in dry mouth symptoms after treatment.
The treatment involves injecting either stem cells or a placebo into the two saliva glands near the jaw, guided by an ultrasound scan. The procedure takes 10 minutes.
Although stem cell treatment has been shown to be safe, safety will be monitored in this study. At all three visits, participants will be asked about any side effects, which will be categorized as serious or mild, and as treatment-related or not. Follow-up and treatment plans will be made for any side effects. Participants will also always have direct access to the treating doctor.
The study will be monitored by the Danish Medicines Agency and the GCP unit, which ensures that all rules and laws are followed.
- Conditions
- Sjorgren's Syndrome
- Being tested
- MSC, Saline Water (Control)
- Keywords
- Mesenchymal stem/stromal cell, MSC, Advanced Therapy Medicinal Product (ATMP),, xerostomia, dry mouth, Sjogren's disease, Sjogren's syndrome, randomized clinical trial (RCT)
- Medical subject headings
- Xerostomia, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCDrug
Allogeneic adipose-derived mesenchymal stromal / stem cells in 10% DMSO
Saline Water (Control)Drug
Isotonic sterile saline water
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Isotone sterile saline water Receives: Drug: Saline Water (Control) |
| MSC | Experimental | Allogeneic adipose-derived stem / stromal cells in 10% DMSO Receives: Drug: MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in unstimulated whole saliva flow rate by sialometry
Measured: From baseline to 4 months after treatment
Secondary outcomes (11)
Change in stimulated whole saliva flow rate by sialometri
Measured: From baseline to 4 and 12 months after treatment
• Safety evaluated by number of serious adverse events (SAE), adverse advents (AE), and deaths
Measured: From baseline to 4 and 12 months after treatment
Quality of the whole saliva measured as changes in percentages in the concentration of electrolytes, total protein, alpha-amylase, and salivary IgA with Elisa assays
The concentrations of the specific electrolyte, total protein and IgA will be compared to reference values.
Measured: From baseline to 4 and 12 months after treatment
Immune response measured by the development of donor specific antibodies
Serum will be frozen until the end of the trial and all samples will be analyzed together. The blood samples will be analyzed for HLA class I and class II antibodies with the Luminex platform (Luminex 200 system or LABScan3D) and will be reported as HLA antibodies present/not present in the samples.
Measured: From baseline to 4 and 12 months after treatment
Lacrimal secretion measured by the Schirmers Test
Measured: From baseline to 4 and 12 months after treatment
• Changes in the gland morphology as assessed by ultrasound
Measured as changes in the OMERACT US system
Measured: From baseline to 4 and 12 months after treatment
• Changes in ESSDAI
Measured: From baseline to 4 and 12 months after treatment
• Changes in ESSPRI
Measured: From baseline to 4 and 12 months after treatment
PROM: Xerostomia Questionnaire
This PROM will be compared by converting to summary-scores ranging from 0-100.
Measured: From baseline to 4 and 12 months after treatment
PROM:Clinical Oral Dryness score.
This outcome will be compared by converting to summary-scores ranging from 0-100
Measured: From baseline to 4 and 12 months after treatment
PROM: Summated Xerostomia Inventory.
This outcome will be compared by converting to summary-scores ranging from 0-100
Measured: From baseline to 4 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start21 Jan 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjorgren's SyndromeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Hansen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805448
- Sponsor's protocol ID
- EU CT: 2024-516715-25-00
- Other IDs
- 2024-516715-25-00
- Acronym
- ASSIX
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to participant level-data and statistical code can be granted through a reasonable request to the corresponding author and subsequent approval from the relevant authorities.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögrens Disease
- ClinicalTrials.gov ID
- NCT06805448
- Acronym / sponsor ID
- ASSIX / EU CT: 2024-516715-25-00
- Conditions
- Sjorgren's Syndrome
- Keywords
- Mesenchymal stem/stromal cell, MSC, Advanced Therapy Medicinal Product (ATMP),, xerostomia, dry mouth, Sjogren's disease, Sjogren's syndrome, randomized clinical trial (RCT)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Feb 2025 (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.
Living with dry mouth significantly impacts daily life, causing constant discomfort. It makes it harder to talk, eat solid food (increasing the risk of malnutrition), swallow, and sleep well. It also raises the risk of tooth decay. One common cause of dry mouth is Sjögren's Syndrome.
Sjögren's Syndrome is a common chronic autoimmune disease. In this disease, the immune system attacks the body's own saliva glands, reducing saliva production and leading to severe dry mouth and its associated symptoms.
Current treatments for dry mouth are temporary and only last a short time (from a few minutes to a few hours). Therefore, new treatment options are needed.
Research has shown that mesenchymal stem cells can be used to treat dry mouth with promising results. These stem cells can be injected into a vein or directly into the saliva glands. Although the exact mechanism is not fully understood, studies suggest that stem cells can positively affect the immune system, reduce inflammation, regenerate tissue, and reverse scarring.
This research group has been studying stem cell treatment for dry mouth for over 10 years and is internationally recognized. The group have conducted three studies where we injected stem cells into the saliva glands of patients with dry mouth due to radiation therapy for head or neck cancer. Results showed a 30%-50% increase in saliva production and a significant reduction in dry mouth symptoms. No studies have yet investigated injecting stem cells into the saliva glands of patients with dry mouth due to Sjögren's Syndrome. One study did inject stem cells into tear glands with promising results. Therefore, this study aim to investigate injecting stem cells into the saliva glands of patients with dry mouth due to Sjögren's Syndrome.
For this study, mesenchymal stem cells harvested from the fat tissue of healthy adult donors is used. This type of stem cell is better at reversing scarring and forming new blood vessels. The procedure is quick and has few side effects, and donors benefit from the fat removal. The fat is typically taken from the abdominal area. Donors are tested for various diseases to ensure they are healthy. Previous studies have shown that the treatment is safe with only a few temporary side effects.
The hypothesis is that injecting stem cells into the saliva glands of patients with dry mouth due to Sjögren's Syndrome will improve saliva production and reduce dry mouth symptoms. The study aims to determine if this treatment increases saliva production and reduces symptoms caused by dry mouth.
To test these hypotheses, the study will include:
- The treatment itself with either stem cells or a placebo (sterile saline).
- Multiple saliva tests to measure saliva production.
- Saliva samples stored for later analysis to see if the saliva's ability to protect teeth and aid digestion changes after stem cell treatment.
- A blood test to examine the immune system's response to the stem cell treatment.
- A clinical examination to see if the stem cell treatment affects Sjögren's Syndrome symptoms elsewhere in the body.
- Questionnaires to assess participants' perceptions of changes in dry mouth symptoms after treatment.
The treatment involves injecting either stem cells or a placebo into the two saliva glands near the jaw, guided by an ultrasound scan. The procedure takes 10 minutes.
Although stem cell treatment has been shown to be safe, safety will be monitored in this study. At all three visits, participants will be asked about any side effects, which will be categorized as serious or mild, and as treatment-related or not. Follow-up and treatment plans will be made for any side effects. Participants will also always have direct access to the treating doctor.
The study will be monitored by the Danish Medicines Agency and the GCP unit, which ensures that all rules and laws are followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Saline Water (Control)Isotone sterile saline water |
| MSC | Experimental | Drug: MSCAllogeneic adipose-derived stem / stromal cells in 10% DMSO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with SS according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) classification criteria for primary SjD (2)
- Age equal or above 18 years
- Persistent xerostomia for at least 3 months
- Unstimulated whole saliva flow rate (UWS) of minimum 0.05 ml/min and maximum 3.0 ml/min
- Capable and willing to receive proper information and to give written informed consent.
Key exclusion criteria (9 listed)
- Current intake of xerogenic medications such as anticholinergics, tricyclic antidepressants, opioids, and certain antihypertensive agents (23)
- Presence of any other diseases of the salivary glands, e.g. xerostomia due to radiation
- Previous submandibular gland surgery
- Previous treatment with any type of stem cells in the salivary glands
- Pregnancy or planned pregnancy within the 12 months study period
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 |
|---|---|---|
| MSCAllogeneic adipose-derived mesenchymal stromal / stem cells in 10% DMSO | Drug | MSC |
| Saline Water (Control)Isotonic sterile saline water | Drug | Placebo |
Primary outcome
Change in unstimulated whole saliva flow rate by sialometry
Time frame: From baseline to 4 months after treatment
11 secondary outcomes
Change in stimulated whole saliva flow rate by sialometri
Time frame: From baseline to 4 and 12 months after treatment
• Safety evaluated by number of serious adverse events (SAE), adverse advents (AE), and deaths
Time frame: From baseline to 4 and 12 months after treatment
Quality of the whole saliva measured as changes in percentages in the concentration of electrolytes, total protein, alpha-amylase, and salivary IgA with Elisa assays
Time frame: From baseline to 4 and 12 months after treatment
Immune response measured by the development of donor specific antibodies
Time frame: From baseline to 4 and 12 months after treatment
Lacrimal secretion measured by the Schirmers Test
Time frame: From baseline to 4 and 12 months after treatment
• Changes in the gland morphology as assessed by ultrasound
Time frame: From baseline to 4 and 12 months after treatment
• Changes in ESSDAI
Time frame: From baseline to 4 and 12 months after treatment
• Changes in ESSPRI
Time frame: From baseline to 4 and 12 months after treatment
PROM: Xerostomia Questionnaire
Time frame: From baseline to 4 and 12 months after treatment
PROM:Clinical Oral Dryness score.
Time frame: From baseline to 4 and 12 months after treatment
PROM: Summated Xerostomia Inventory.
Time frame: From baseline to 4 and 12 months after treatment
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 3 Feb 2025.
- Individual participant dataSharing planned: Yes. Access to participant level-data and statistical code can be granted through a reasonable request to the corresponding author and subsequent approval from the relevant authorities.
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 Phase 1/2 study testing MSC in people with Sjorgren's Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Feb 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Joachim Hansen, M.D, PhD-fellow (+4523312552, joachim.hansen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in unstimulated whole saliva flow rate by sialometry (time frame: From baseline to 4 months after treatment). 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 3 Feb 2025.