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Naslov:Post-radiation xerostomia therapy with allogeneic mesenchymal stromal stem cells in patients with head and neck cancer : study protocol for phase I clinical trial
Avtorji:ID Strojan, Primož (Avtor)
ID Plavc, Gaber (Avtor)
ID Kokalj, Marko (Avtor)
ID Mitrović, Goran (Avtor)
ID Blatnik, Olga (Avtor)
ID Ležaič, Luka (Avtor)
ID Sočan, Aljaž (Avtor)
ID Bavec, Aljoša (Avtor)
ID Tešić, Nataša (Avtor)
ID Pretnar-Hartman, Katrina (Avtor)
ID Švajger, Urban (Avtor)
Datoteke:URL URL - Izvorni URL, za dostop obiščite https://www.radioloncol.com/index.php/ro/article/view/4197
 
.pdf PDF - Predstavitvena datoteka, prenos (1,91 MB)
MD5: EE715E2A0F8E8674F3624515CC94FDE5
 
Jezik:Angleški jezik
Tipologija:1.01 - Izvirni znanstveni članek
Organizacija:Logo OI - Onkološki inštitut Ljubljana
Povzetek: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.
Ključne besede:oropharyngeal cancer, xerostomia, mesenchymal stromal stem cells
Status publikacije:Objavljeno
Verzija publikacije:Objavljena publikacija
Datum objave:01.01.2023
Založnik:Association of Radiology and Oncology
Leto izida:2023
Št. strani:str. 538-549
Številčenje:Vol. 57, no. 4
Izvor:Ljubljana
PID:20.500.12556/DiRROS-19887 Novo okno
UDK:602.9:616-006
ISSN pri članku:1318-2099
DOI:10.2478/raon-2023-0052 Novo okno
COBISS.SI-ID:173952003 Novo okno
Avtorske pravice:by Authors
Datum objave v DiRROS:26.07.2024
Število ogledov:515
Število prenosov:243
Metapodatki:XML DC-XML DC-RDF
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Gradivo je del revije

Naslov:Radiology and oncology
Skrajšan naslov:Radiol. oncol.
Založnik:Slovenian Medical Society - Section of Radiology, Croatian Medical Association - Croatian Society of Radiology
ISSN:1318-2099
COBISS.SI-ID:32649472 Novo okno

Gradivo je financirano iz projekta

Financer:ARIS - Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije
Številka projekta:P3-0307-2019
Naslov:Rak glave in vratu - analiza bioloških značilnosti in poskus izboljšanja zdravljenja

Licence

Licenca:CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
Povezava:http://creativecommons.org/licenses/by/4.0/deed.sl
Opis:To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.

Sekundarni jezik

Jezik:Slovenski jezik
Ključne besede:orofaringealni rak, kserostomija, mezenhimske stromalne matične celice


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