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Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
EU CTIS ID: 2025-522559-25-00
What this study is testing
To evaluate the effect of two repeated intraglandular injections with ASCs, relative to placebo, in improving unstimulated whole salivary flow rate in radiation-induced xerostomia 8 months from baseline.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- UWS of 0.05 mL/min to 0.5 ml/min
- 5. Age above 18
- 6. Informed consent
You likely can't join if
- 1. Any active cancer in the previous 0,5 year (not including the head and neck cancer and basocellular carcinomas)
- 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
See the full eligibility 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
- UWS of 0.05 mL/min to 0.5 ml/min
- 5. Age above 18
- 6. Informed consent
- 1. Any active cancer in the previous 0,5 year (not including the head and neck cancer and basocellular carcinomas)
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.