Post-radiation xerostomia therapy with allogeneic mesenchymal stromal stem cells in patients with head and neck cancer : study protocol for phase I clinical trial

Strojan, Primož (author), Plavc, Gaber (author), Kokalj, Marko (author), Mitrović, Goran (author), Blatnik, Olga (author), Ležaič, Luka (author), Sočan, Aljaž (author), Bavec, Aljoša (author), Tešić, Nataša (author), Pretnar-Hartman, Katrina (author), Švajger, Urban (author)

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.

• Language: English
• Keywords: oropharyngeal cancer, xerostomia, mesenchymal stromal stem cells
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy; MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2023
• Number of pages: Str. 538-549
• Numbering: Vol. 57, no. 4
• PID: 20.500.12556/RUL-152559
• UDC: 602.9:616-006
• ISSN on article: 1581-3207
• COBISS.SI-ID: 173952003
• Publication date in RUL: 28.11.2023

Record is a part of a journal

• Title: Radiology and oncology
• Publisher: Association of Radiology and Oncology
• ISSN: 1581-3207
• COBISS.SI-ID: 784507

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, mezenhimske matične celice, rak (medicina)

Projects

• Funder: ARRS - Slovenian Research Agency
• Project number: P3-0307
• Name: Rak glave in vratu - analiza bioloških značilnosti in poskus izboljšanja zdravljenja