Mesenchymal Stem/Stromal Cell Therapy for Radiation-Induced Xerostomia in Previous Head and Neck Cancer Patients: A Phase II Randomized, Placebo-Controlled Trial

Kathrine Kronberg Jakobsen*, Amanda Louise Fenger Carlander, Tobias Todsen, Jacob Melchiors, Natasja Paaske, Anne Kathrine Ostergaard Madsen, Simone Kloch Bendtsen, Christine Mordhorst, Helene Stampe, Jens Kastrup, Annette Ekblond, Mandana Haack-Sørensen, Mohammad Farhadi, Christian Maare, Jeppe Friborg, Charlotte D. Lynggaard, Anne Werner Hauge, Robin Christensen, Christian Grønhøj, Christian von Buchwald

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

4 Citationer (Scopus)

Abstract

Purpose: No effective treatment exists for radiation-induced xerostomia. The objective of this study was to compare the effect of adipose-derived mesenchymal stem/stromal cell (ASC) injection, relative to placebo, on salivary gland function in patients with radiation-induced xerostomia. Patient and Methods: In this single-centre, double-blind, placebo- controlled trial, patients with hyposalivation were randomised to receive ultrasound-guided injections of allogeneic ASCs or placebo into the submandibular glands. Patients were followed for 4 months. We evaluated unstimulated whole salivary flow rate (UWS), stimulated salivary flow rate, and patient-reported outcomes. Adverse events were recorded and immune response determined in blood samples. Results: We enrolled 120 patients. ASC treatment resulted in a statistically significant UWS increase of 0.04 [95% confidence interval (CI), 0.02-0.06] mL/min (38%) compared with pretreatment baseline whereas placebo treatment did not cause a significant increase [0.01 (95% CI, -0.01 to 0.04) mL/min (21%)]. Both the ASC and placebo treatment yielded notable symptom reductions, with dry mouth decreasing by 13.6 and 7.7 units, sticky saliva decreased by 14.8 and 9.3 units, swallowing difficulties decreased by 7.9 and 8.0 units, and the summary score of the Xerostomia Questionnaire decreased 5.9 and 5.1 units for the ASC and placebo arms, respectively. We found no statistically significant group difference between the ASC and placebo arms for any of the outcomes. Conclusions: We could not confirm superiority of the ASC relative to placebo. ASC therapy significantly improved UWS in previous patients with head and neck cancer, whereas placebo resulted in an insignificant increase.

OriginalsprogEngelsk
TidsskriftClinical Cancer Research
Vol/bind30
Udgave nummer10
Sider (fra-til)2078-2084
Antal sider7
ISSN1078-0432
DOI
StatusUdgivet - 15 maj 2024

Bibliografisk note

Funding Information:
The study received funding from the nonprofit Candys Foundation (Grant # 2020\u2013 352) and Copenhagen University Hospital - Rigshospitalet (no grant number). Section for Biostatistics and Evidence-Based Research, the Parker Institute, is supported by a core grant from the Oak Foundation (OCAY-18\u2013774-OFIL).

Publisher Copyright:
© 2024 The Authors.

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