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

NCT07290946 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Xerostomia Due to Hyposecretion of Salivary Gland
  • Xerostomia Due to Radiotherapy
  • Sjögren´s Syndrome

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

Sponsors & Collaborators

  • Christian von Buchwald

    lead OTHER

Principal Investigators

  • Christian von Buchwald, MD, Professor · Copenhagen University Hospital - Rigshospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-06-30
Completion
2028-12-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290946 on ClinicalTrials.gov