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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522559-25-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stem Cells | Experimental | Treatment with intraglandular injections in both submandibular glands with allogeneic adipose derived mesenchymal stem cells |
|
| Placebo | Placebo Comparator | Treatment with intraglandular injections in both submandibular glands sterile isotonic saline water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS | Drug | Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unstimulated whole salivary flow rate | Unstimulated whole salivary flow rate measured in mL/min | T=0 months, T=4 months and T=8 months (primary endpoint assessed after 8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulated whole salivary flow rate | Stimulated whole salivary flow rate measured in mL/min | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events and serious adverse events | Evaluated by serious adverse events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), treatment-related adverse events, and deaths. | Continually assessed from inclusion (T=0 months) to last visit (T=24 months). |
| Outcome 1 to 6 assessed at long term follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joachim Hansen, M.D | Contact | +4523312552 | joachim.hansen.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Christian von Buchwald, MD, Professor | Copenhagen University Hospital - Rigshospital | Study Chair |
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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.
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One research assistant preparing the treatments are unmasked
| Placebo | Drug | Sterile isotonic saline water |
|
For evaluation of the participants´ perception of xerostomia, the participants will answer validated questionnaires in Danish. |
| 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:
| 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) | 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. | T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months). |
| T=0 months, T=4 months, T=8 months, T=12 months, and T=24 months |
| 5-point transition scale for determining the minimal important difference (evaluated at 8 months) | The 5-point transition scale is critical in the exploratory secondary objective of developing Minimal Important Differences (MIDs) for all the outcome measures applied in the trial because it provides a subjective, patient-centered anchor to assess meaningful change. The scale, which typically ranges from "much worse" to "much better," captures participants' perceptions of change in their condition over time. By linking participants' responses on this scale to corresponding changes in clinical outcome measures, the transition scale helps identify the smallest change in those measures that is considered important or beneficial by the participants themselves. This subjective assessment of change is essential for establishing MIDs, as it ensures that the derived thresholds reflect clinically relevant improvements or deteriorations from the patients' perspectives. | T=4 months, T=8 months. |
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D014987 | Xerostomia |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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