Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth (NCT03874572) | Clinical Trial Compass
UnknownPhase 1
Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth
Denmark10 participantsStarted 2019-03-18
Plain-language summary
An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age between 18-75 years
✓. Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017)
✓. 2 years' follow-up without recurrence
✓. Clinically reduced salivation and hyposalivation, evaluated by a screening
✓. Unstimulated salivary flow rate between 0.2mL/min and 0.05mL/min
✓. Grade 2-3 xerostomia (CTCAEv5.0)
✓. WHO Performance status (PS) 0-1
✓. Informed consent
Exclusion criteria
✕. Any cancer in the previous 4 years (not including OPSCC and basocellular carcinomas)
✕. Xerogenic medications
✕. Penicillin or Streptomycin allergy
✕. Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis
✕. Previous parotid or submandibular gland surgery
✕. Previous treatment with any type of stem cells
✕. Breastfeeding, Pregnancy or planned pregnancy within the next 2 years
What they're measuring
1
Safety: Number of patients with serious adverse events