医学
间充质干细胞
头颈部癌
安慰剂
放射治疗
头颈部
癌症
间质细胞
肿瘤科
外科
内科学
病理
替代医学
作者
Kathrine Kronberg Jakobsen,Amanda-Louise Fenger Carlander,Tobias Todsen,Jacob Melchiors,Natasja Paaske,Anders Madsen,Simone K. Bendtsen,Christine Mordhorst,Helene Stampe,Jens Kastrup,Annette Ekblond,Mandana Haack‐Sørensen,Mohammad Hassan Farhadi,Christian Maare,Jeppe Friborg,Charlotte Duch Lynggaard,Anne Werner Hauge,Robin Christensen,Christian Grónhøj Larsen,Christian von Buchwald
标识
DOI:10.1158/1078-0432.ccr-23-3675
摘要
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 four 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% CI 0.02 to 0.06] mL/min (38%) compared to pre-treatment baseline whereas placebo treatment did not cause a significant increase (0.01 [-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 units and 7.7 units, sticky saliva decreased by 14.8 units 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 units and 5.1 units for the ASC and placebo-arm, respectively. We found no statistically significant group difference between the ASC and placebo-arm for any of the outcomes. Conclusion: We could not confirm superiority of the ASC relative to placebo. ASC therapy significantly improved UWS in previous head and neck cancer patients, whereas placebo resulted in an insignificant increase.
科研通智能强力驱动
Strongly Powered by AbleSci AI