Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors

Browse trials for

• Sjogren's Syndrome 371
• Xerostomia 254
• Head and Neck Neoplasms 2,344

Keywords

• Mesenchymal Stem Cell
• Sjögren
• Radiation
• xerostomia
• Head and Neck cancer

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 244 interventional studies indexed under Sjogren's Syndrome.

Lead sponsor

Christian von Buchwald is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Study arms

• Experimental
  Mesenchymal Stem Cells

  Treatment with intraglandular injections in both submandibular glands with allogeneic adipose derived mesenchymal stem cells

  Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

• Placebo comparator
  Placebo

  Treatment with intraglandular injections in both submandibular glands sterile isotonic saline water

  Drug: Placebo

Interventions

• DrugALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

  Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.

• DrugPlacebo

  Sterile isotonic saline water

Primary outcomes

1. Unstimulated whole salivary flow rate

   Unstimulated whole salivary flow rate measured in mL/min

   Time frame: T=0 months, T=4 months and T=8 months (primary endpoint assessed after 8 months)

Secondary outcomes

1. Stimulated whole salivary flow rate

   Stimulated whole salivary flow rate measured in mL/min

   Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

2. 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.

   Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

3. 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

   Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

4. Immune response

   Measured by positivity of de novo drug specific antibodies (binary outcome)

   Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

5. 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.

   Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

Other outcomes

1. 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.

   Time frame: Continually assessed from inclusion (T=0 months) to last visit (T=24 months).

2. Outcome 1 to 6 assessed at long term follow-up

   Time frame: T=0 months, T=4 months, T=8 months, T=12 months, and T=24 months

3. 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.

   Time frame: T=4 months, T=8 months.

Individual participant data

Plan to share: 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.