NCT07290946Not yet recruitingPhase 2
Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- Dec 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Christian von Buchwald
- Diseases
- Sjögren's disease, Head and neck cancer
- NCT number
- NCT07290946
- EU CT number
- 2025-522559-25-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From Dec 2025 to the primary completion date, Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Xerogenic medications at inclusion
- Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)
- Previous submandibular surgery or biopsy
Other illness
- Any malignant cancer diagnosis excluding head and neck cancers
- Penicillin or streptomycin allergy assessed by health personnel
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.