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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
Authors:ID Strojan, Primož (Author)
ID Plavc, Gaber (Author)
ID Kokalj, Marko (Author)
ID Mitrović, Goran (Author)
ID Blatnik, Olga (Author)
ID Ležaič, Luka (Author)
ID Sočan, Aljaž (Author)
ID Bavec, Aljoša (Author)
ID Tešić, Nataša (Author)
ID Pretnar-Hartman, Katrina (Author)
ID Švajger, Urban (Author)
Files:URL URL - Source URL, visit https://www.radioloncol.com/index.php/ro/article/view/4197
 
.pdf PDF - Presentation file, download (1,91 MB)
MD5: EE715E2A0F8E8674F3624515CC94FDE5
 
Language:English
Typology:1.01 - Original Scientific Article
Organization:Logo OI - Institute of Oncology
Abstract: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.
Keywords:oropharyngeal cancer, xerostomia, mesenchymal stromal stem cells
Publication status:Published
Publication version:Version of Record
Publication date:01.01.2023
Publisher:Association of Radiology and Oncology
Year of publishing:2023
Number of pages:str. 538-549
Numbering:Vol. 57, no. 4
Source:Ljubljana
PID:20.500.12556/DiRROS-19887 New window
UDC:602.9:616-006
ISSN on article:1318-2099
DOI:10.2478/raon-2023-0052 New window
COBISS.SI-ID:173952003 New window
Copyright:by Authors
Publication date in DiRROS:26.07.2024
Views:712
Downloads:322
Metadata:XML DC-XML DC-RDF
:
STROJAN, Primož, PLAVC, Gaber, KOKALJ, Marko, MITROVIĆ, Goran, BLATNIK, Olga, LEŽAIČ, Luka, SOČAN, Aljaž, BAVEC, Aljoša, TEŠIĆ, Nataša, PRETNAR-HARTMAN, Katrina and ŠVAJGER, Urban, 2023, Post-radiation xerostomia therapy with allogeneic mesenchymal stromal stem cells in patients with head and neck cancer : study protocol for phase I clinical trial. Radiology and oncology [online]. 2023. Vol. 57, no. 4, p. 538–549. [Accessed 23 March 2025]. DOI 10.2478/raon-2023-0052. Retrieved from: https://dirros.openscience.si/IzpisGradiva.php?lang=eng&id=19887
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Record is a part of a journal

Title:Radiology and oncology
Shortened title:Radiol. oncol.
Publisher:Slovenian Medical Society - Section of Radiology, Croatian Medical Association - Croatian Society of Radiology
ISSN:1318-2099
COBISS.SI-ID:32649472 New window

Document is financed by a project

Funder:ARIS - Slovenian Research and Innovation Agency
Project number:P3-0307-2019
Name:Rak glave in vratu - analiza bioloških značilnosti in poskus izboljšanja zdravljenja

Licences

License:CC BY 4.0, Creative Commons Attribution 4.0 International
Link:http://creativecommons.org/licenses/by/4.0/
Description:This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

Language:Slovenian
Keywords:orofaringealni rak, kserostomija, mezenhimske stromalne matične celice


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