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Post-radiation xerostomia therapy with allogeneic mesenchymal stromal stem cells in patients with head and neck cancer : study protocol for phase I clinical trialStrojan, Primož ...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.Source: Radiology and oncology. - ISSN 1318-2099 (Vol. 57, no. 4, 2023, str. 538-549)Type of material - article, component part ; adult, seriousPublish date - 2023Language - englishCOBISS.SI-ID - 173952003
Author
Strojan, Primož |
Plavc, Gaber |
Kokalj, Marko, zdravnik |
Mitrović, Goran, dr. med. |
Blatnik, Olga |
Ležaič, Luka |
Sočan, Aljaž |
Bavec, Aljoša |
Tešić, Nataša |
Pretnar-Hartman, Katrina |
Švajger, Urban
Topics
Mezenhimske matične celice |
Rak (medicina) |
oropharyngeal cancer |
xerostomia |
mesenchymal stromal stem cells |
orofaringealni rak |
kserostomija |
mezenhimske stromalne matične celice
Author | Strojan, Primož ... |
Title | Post-radiation xerostomia therapy with allogeneic mesenchymal stromal stem cells in patients with head and neck cancer : study protocol for phase I clinical trial |
Publication date | 2023-11-27 |
COBISS.SI-ID | 173952003 |
Publication version in repository | Publisher's version |
Publication licence | Creative Commons Attribution 4.0 International |
Embargo | Immediate publication for public |
Project(s) from which the publication was funded
Title | Acronym | Project ID | Funder |
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Rak glave in vratu - analiza bioloških značilnosti in poskus izboljšanja zdravljenja | P3-0307-2019 |
Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije |
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https://www.radioloncol.com/index.php/ro/article/view/4197 |
https://repozitorij.uni-lj.si/IzpisGradiva.php?id=152559 |
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Strojan, Primož | 14576 |
Plavc, Gaber | 38481 |
Kokalj, Marko, zdravnik | 51868 |
Mitrović, Goran, dr. med. | |
Blatnik, Olga | 28514 |
Ležaič, Luka | 22346 |
Sočan, Aljaž | 29238 |
Bavec, Aljoša | 16130 |
Tešić, Nataša | 34477 |
Pretnar-Hartman, Katrina | 15978 |
Švajger, Urban | 26198 |
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