Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells
Xerostomia Following Radiotherapy
About this trial
This is an interventional treatment trial for Xerostomia Following Radiotherapy focused on measuring post-radiation xerostomia, allogenic mesenchyma stromal stem cells, toxicity, effectiveness
Eligibility Criteria
Inclusion Criteria: squamous cell carcinoma of the oropharynx, Union for International Cancer Control TNM Classification of Malignant Tumors )8th ed.) clinical stage T1-2N+ or cT3-4cN0-3 M0, treated with curative intent radiotherapy (tumor dose 66-70 Gy, bilateral neck irradiation) with or without concurrent chemotherapy 2 years or more post-treatment without signs of locoregional recurrence or systemic metastasis non-smoker or former smoker (quit smoking ≥2 years ago) mean radiation dose >26 Gy to each of the parotid glands and >35 Gy to each of the submandibular glands xerostomia of grade 2 or 3, assessed according to the CTCAE v5.0 scale Clinically reduced salivary flow and hyposalivation (unstimulated whole saliva flow rate 0.05-0.20 ml/min) age between 18-75 years both sexes signed "Informed Consent Form" for participation in the study Exclusion Criteria: newly diagnosed malignancy anywhere in the body within the past two years active smoker use of medications with potential to cause dry mouth (e.g., tricyclic antidepressants, antipsychotics, decongestants, bronchodilators, antihypertensives like beta-blockers and diuretics, antihistamines, hypnotic sedatives, opioids, and muscle relaxants) other salivary gland diseases (e.g., Sjögren's syndrome, scleroderma, sialolithiasis, etc.) patients on anticoagulant therapy that cannot be discontinued during the intervention pregnancy or planned pregnancy within the next two years breastfeeding active, uncontrolled infection or other medical (including psychiatric) conditions that, in the researchers' opinion, do not allow for the safe administration of the planned therapy and performance of the follow-up procedures known substance abuse or alcoholism
Sites / Locations
- Blood Transfusion Center of Slovenia
- Institute of Oncology Ljubljana
- University Clinical Center Ljubljana
- University of Ljubljana
Arms of the Study
Arm 1
Experimental
allogeneic mesenchymal stromal stem cells
Application of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) under ultrasound guidance into both parotid and submandibular glands.