20.500.12556/DiRROS-19887 Post-radiation xerostomia therapy with allogeneic mesenchymal stromal stem cells in patients with head and neck cancer study protocol for phase I clinical trial Background: Xerostomia is a common side effect of radiotherapy in patients with head and neck tumors that negatively affects quality of life. There is no known effective standard treatment for xerostomia. Here, we present the study protocol used to evaluate the safety and preliminary efficacy of allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue. Methods: Ten oropharyngeal cancer patients with post-radiation xerostomia and no evidence of disease recurrence 2 or more years after (chemo)irradiation (intervention group) and 10 healthy volunteers (control group) will be enrolled in this nonrandomized, open-label, phase I exploratory study. MSCs from umbilical cord tissue will be inserted under ultrasound guidance into both parotid glands and both submandibular glands of the patients. Toxicity of the procedure will be assessed according to CTCAE v5.0 criteria at days 0, 1, 5, 28, and 120. Efficacy will be assessed by measuring salivary flow and analyzing its composition, scintigraphic evaluation of MSC grafting, retention, and migration, and questionnaires measuring subjective xerostomia and quality of life. In addition, the radiological, functional, and morphological characteristics of the salivary tissue will be assessed before, at 4 weeks, and at 4 months after the procedure. In the control group subjects, only salivary flow rate and salivary composition will be determined. Discussion: The use of allogeneic MSCs from umbilical cord tissue represents an innovative approach for the treatment of xerostomia after radiation. Due to the noninvasive collection procedure, flexibility of cryobanking, and biological advantages, xerostomia therapy using allogeneic MSCs from umbilical cord tissue may have an advantage over other similar therapies. oropharyngeal cancer xerostomia mesenchymal stromal stem cells orofaringealni rak kserostomija mezenhimske stromalne matične celice true false true Association of Radiology and Oncology Ljubljana Angleški jezik Slovenski jezik by Authors Neznano 2024-07-26 10:43:54 2024-07-26 10:43:54 2024-07-30 03:35:16 0000-00-00 00:00:00 2023 0 0 str. 538-549 no. 4 Vol. 57 2023 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 2023-01-01 602.9:616-006 1318-2099 10.2478/raon-2023-0052 173952003 https://www.radioloncol.com/index.php/ro/article/view/4197 1 6fb3184a-4b1a-11ef-b487-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=27581 RAZ_Strojan_Primoz_2023.pdf RAZ_Strojan_Primoz_2023.pdf 1 EE715E2A0F8E8674F3624515CC94FDE5 00deb61d5e3fc0c6ad336e94d5c5c98760801d860fa93c4df451b2e92548c16b 9e11e86f-4b1a-11ef-b487-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=27582 Onkološki inštitut Ljubljana 0 0 0