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

Christian von Buchwald

Status and phase: Not yet enrolling; Phase 2

Conditions: Xerostomia Due to Hyposecretion of Salivary Gland; Sjögren´s Syndrome; Xerostomia Due to Radiotherapy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07290946

2025-522559-25-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity
2. WHO Performance status 0-1
3. Presence of xerostomia daily
4. UWS of 0.05 mL/min to 0.5 ml/min
5. Age above 18
6. Informed consent
7. 0.5 year follow-up of the cancers in 1. with no recurrence

Exclusion criteria

1. Any malignant cancer diagnosis excluding head and neck cancers
2. Xerogenic medications at inclusion
3. Penicillin or streptomycin allergy assessed by health personnel
4. Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)
5. Previous submandibular surgery or biopsy
6. Pregnancy or planned pregnancy until 4 months after second treatment
7. Breastfeeding
8. Smoking within the last 6 months
9. Alcohol abuse within the last 6 months (consumption must not be above 10 units/week (Danish National board health alcohol guidelines)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Mesenchymal Stem Cells

Experimental group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo