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Not yet recruiting NCT07290946

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

Phase II Interventional Xerostomia Due to Hyposecretion of Salivary Gland Xerostomia Due to Radiotherapy Sjögren´s Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS, Placebo.
Who it may be relevant to
Registry conditions: Xerostomia Due to Hyposecretion of Salivary Gland, Xerostomia Due to Radiotherapy, Sjögren´s Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
    Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.
  • Drug Placebo
    Sterile isotonic saline water

Primary outcome measures

  • Unstimulated whole salivary flow rate [Time frame: T=0 months, T=4 months and T=8 months (primary endpoint assessed after 8 months)]
Secondary outcome measures (5)
  • 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).]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07290946 · 2025-522559-25-00 · 2025-522559-25-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗