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Clinical Trials/NCT07290946
NCT07290946Not yet recruitingPhase 2

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

Christian von Buchwald0 sites100 target enrollmentStarted: December 1, 2025Last updated:
Interventions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
100
Primary Endpoint
Unstimulated whole salivary flow rate

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

One research assistant preparing the treatments are unmasked

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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)

Arms & Interventions

Mesenchymal Stem Cells

Experimental

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

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

Placebo

Placebo Comparator

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

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Stimulated whole salivary flow rate(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).(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).(T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).)
  • Immune response(T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).)
  • Patient Reported Outcome: Goal Attainment Scale (GAS)(T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).)

Investigators

Sponsor
Christian von Buchwald
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Christian von Buchwald

MD, DMSc, professor

Rigshospitalet, Denmark

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