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

Posted on 2024-05-15 - 07:23
AbstractPurpose:

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.

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Copenhagen University Hospital, Rigshospitalet

Candys Foundation

The Oak Foundation

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AUTHORS (20)

Kathrine Kronberg Jakobsen
Amanda-Louise Fenger Carlander
Tobias Todsen
Jacob Melchiors
Natasja Paaske
Anne Kathrine Østergaard 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
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