Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
NCT ID: NCT07290946
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-12-31
2028-12-31
Brief Summary
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The hypothesis is that two treatments of mesenchymal stem cells results in a higher salivary flow rate and ameliorate symptoms from dry mouth.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mesenchymal Stem Cells
Treatment with intraglandular injections in both submandibular glands with allogeneic adipose derived mesenchymal stem cells
ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.
Placebo
Treatment with intraglandular injections in both submandibular glands sterile isotonic saline water
Placebo
Sterile isotonic saline water
Interventions
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ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.
Placebo
Sterile isotonic saline water
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Christian von Buchwald
OTHER
Responsible Party
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Christian von Buchwald
MD, DMSc, professor
Principal Investigators
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Christian von Buchwald, MD, Professor
Role: STUDY_CHAIR
Copenhagen University Hospital - Rigshospital
Central Contacts
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Other Identifiers
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2025-522559-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
2025-522559-25-00
Identifier Type: -
Identifier Source: org_study_id