Xerostomia Due to Hyposecretion of Salivary GlandPhase 2MESRIX-moreNCT07290946
Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
A Phase 2 study testing ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS in people with Xerostomia Due to Hyposecretion of Salivary Gland and Xerostomia Due to Radiotherapy, run by Christian von Buchwald.
Trial summary
Dry mouth leads to debilitating symptoms 24/7. The two primary causes for dry mouth are Sjögrens disease and after radiotherapy of a head and neck cancer. Former clinical trials have investigated mesenchymal stem cell treatment for dry mouth with promising results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia Due to Hyposecretion of Salivary Gland, Xerostomia Due to Radiotherapy, Sjögren´s Syndrome
- What is being tested?
- ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2028
- Phase
- Phase 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
- Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity
- WHO Performance status 0-1
- Presence of xerostomia daily
- UWS of 0.05 mL/min to 0.5 ml/min
- Age above 18
- Informed consent
- 0.5 year follow-up of the cancers in 1. with no recurrence
Who cannot join
- Any malignant cancer diagnosis excluding head and neck cancers
- Xerogenic medications at inclusion
- Penicillin or streptomycin allergy assessed by health personnel
- Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)
- Previous submandibular surgery or biopsy
- Pregnancy or planned pregnancy until 4 months after second treatment
Show all 9Show fewer
- Breastfeeding
- Smoking within the last 6 months
- Alcohol abuse within the last 6 months (consumption must not be above 10 units/week (Danish National board health alcohol guidelines)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Dry mouth leads to debilitating symptoms 24/7. The two primary causes for dry mouth are Sjögrens disease and after radiotherapy of a head and neck cancer. Former clinical trials have investigated mesenchymal stem cell treatment for dry mouth with promising results. However, few of the participants evolved normal salivary flow rate. Therefore, in this randomized clinical trial, two treatments of mesenchymal stem cells are administered, 4 months apart. This has not been done before.
The hypothesis is that two treatments of mesenchymal stem cells results in a higher salivary flow rate and ameliorate symptoms from dry mouth.
- Conditions
- Xerostomia Due to Hyposecretion of Salivary Gland, Xerostomia Due to Radiotherapy, Sjögren´s Syndrome
- Being tested
- ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS, Placebo
- Keywords
- Mesenchymal Stem Cell, Sjögren, Radiation, xerostomia, Head and Neck cancer
- Medical subject headings
- Sjogren's Syndrome, Xerostomia, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLSDrug
Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.
PlaceboDrug
Sterile isotonic saline water
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem Cells | Experimental | Treatment with intraglandular injections in both submandibular glands with allogeneic adipose derived mesenchymal stem cells Receives: Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS |
| Placebo | Placebo comparator | Treatment with intraglandular injections in both submandibular glands sterile isotonic saline water Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unstimulated whole salivary flow rate
Unstimulated whole salivary flow rate measured in mL/min
Measured: T=0 months, T=4 months and T=8 months (primary endpoint assessed after 8 months)
Secondary outcomes (5)
Stimulated whole salivary flow rate
Stimulated whole salivary flow rate measured in mL/min
Measured: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Patient-Reported Outcome of xerostomia: The Groningen Radiotherapy-Induced Xerostomia questionnaire (GRIX).
For evaluation of the participants´ perception of xerostomia, the participants will answer validated questionnaires in Danish.
Measured: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Patient-Reported Outcome of xerostomia: The European organization for research and treatment of cancer quality of life questionnaire, head and neck-35 (EORTC QLQ-H&N35).
For evaluation of the participants´ perception of xerostomia, the participants will answer validated questionnaires in Danish. Patients will fill out the EORTC-QLQ- H\&N35 (evaluates overall implications of the xerostomia) for the following domains:
- HNDR: dry mouth
- HNSS: sticky saliva
- HNSW: swallowing
Measured: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Immune response
Measured by positivity of de novo drug specific antibodies (binary outcome)
Measured: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Patient Reported Outcome: Goal Attainment Scale (GAS)
Goal attainment Scale (GAS) was developed in 1968 for assessing outcomes in mental health and has since been updated[36]. Now it is used in a wide variety of settings. It is a qualitative patient reported outcome measure. GAS can be beneficial in drug trials where patients have heterogenic symptoms of the disease[37]. The patient, supported by the health professional, picks 3 personal goals to be measured throughout the study period. The goals must be related to the disease and treatment. In this study 3 goals could be: 1. Ability to sleep better at night, ability to eat more solid foods, and less mouth pain. The goals are evaluated at baseline and at each follow up, following the scoring system seen in figure 1. Statistics are calculated from T-scores.
Measured: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerostomia Due to Hyposecretion of Salivary GlandStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian von Buchwald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian von Buchwald, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian von Buchwald, MD, Professor, Study chair, Copenhagen University Hospital - Rigshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290946
- Sponsor's protocol ID
- 2025-522559-25-00
- Other IDs
- 2025-522559-25-00, 2025
- Acronym
- MESRIX-more
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to national legislations, few data is anonymized. Therefore, we do not plan to share IPD, unfortunately. However, if it will be possible, this page will be updated.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
- ClinicalTrials.gov ID
- NCT07290946
- Acronym / sponsor ID
- MESRIX-more / 2025-522559-25-00
- Conditions
- Xerostomia Due to Hyposecretion of Salivary Gland, Xerostomia Due to Radiotherapy, Sjögren´s Syndrome
- Keywords
- Mesenchymal Stem Cell, Sjögren, Radiation, xerostomia, Head and Neck cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christian von BuchwaldUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Dec 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.
Dry mouth leads to debilitating symptoms 24/7. The two primary causes for dry mouth are Sjögrens disease and after radiotherapy of a head and neck cancer. Former clinical trials have investigated mesenchymal stem cell treatment for dry mouth with promising results. However, few of the participants evolved normal salivary flow rate. Therefore, in this randomized clinical trial, two treatments of mesenchymal stem cells are administered, 4 months apart. This has not been done before.
The hypothesis is that two treatments of mesenchymal stem cells results in a higher salivary flow rate and ameliorate symptoms from dry mouth.
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 |
|---|---|---|
| Mesenchymal Stem Cells | Experimental | Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLSTreatment with intraglandular injections in both submandibular glands with allogeneic adipose derived mesenchymal stem cells |
| Placebo | Placebo comparator | Drug: PlaceboTreatment with intraglandular injections in both submandibular glands sterile isotonic saline water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity
- WHO Performance status 0-1
- Presence of xerostomia daily
- UWS of 0.05 mL/min to 0.5 ml/min
- Age above 18
Key exclusion criteria (9 listed)
- Any malignant cancer diagnosis excluding head and neck cancers
- Xerogenic medications at inclusion
- Penicillin or streptomycin allergy assessed by health personnel
- Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)
- Previous submandibular surgery or biopsy
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 |
|---|---|---|
| ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLSSuspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark. | Drug | Mesenchymal Stem Cells |
| PlaceboSterile isotonic saline water | Drug | Placebo |
Primary outcome
Unstimulated whole salivary flow rate
Time frame: T=0 months, T=4 months and T=8 months (primary endpoint assessed after 8 months)
Unstimulated whole salivary flow rate measured in mL/min
5 secondary outcomes
Stimulated whole salivary flow rate
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Patient-Reported Outcome of xerostomia: The Groningen Radiotherapy-Induced Xerostomia questionnaire (GRIX).
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Patient-Reported Outcome of xerostomia: The European organization for research and treatment of cancer quality of life questionnaire, head and neck-35 (EORTC QLQ-H&N35).
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Immune response
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Patient Reported Outcome: Goal Attainment Scale (GAS)
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 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 18 Dec 2025.
- Individual participant dataSharing planned: No. Due to national legislations, few data is anonymized. Therefore, we do not plan to share IPD, unfortunately. However, if it will be possible, this page will be updated.
Related trials for Xerostomia Due to Hyposecretion of Salivary Gland
Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
RecruitingObservational study
Screening of Biomarkers and Related Mechanisms for RIX
Xerostomia Due to Radiotherapy (Disorder)
Active, not recruitingPhase 3
Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine
Xerostomia
Enrolling by invitationPhase 1/2
Hyaluronic Acid in the Treatment of Hyposalivation
Xerostomia Due to Hyposecretion of Salivary Gland
RecruitingPhase 1/2
Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögren's Disease
Sjorgren's Syndrome
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.
Christian von Buchwald, MD, Professor study chair
Copenhagen University Hospital - Rigshospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS in people with Xerostomia Due to Hyposecretion of Salivary Gland and Xerostomia Due to Radiotherapy, run by Christian von Buchwald.
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 7 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: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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 (+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?
Unstimulated whole salivary flow rate (time frame: T=0 months, T=4 months and T=8 months (primary endpoint assessed after 8 months)). 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 18 Dec 2025.