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Purpose: Mesenchymal stem/stromal cell therapy may reduce radiation-induced xerostomia. We investigated the long-term safety of autologous adipose tissue-derived mesenchymal stem/stromal cells (ASC) injections into the submandibular glands. Patients and Methods: A investigator-initiated, randomized, single-center, placebo-controlled trial. Previous oropharyngeal squamous cell carcinoma patients with radiation-induced xerostomia were randomly (1:1) allocated to receive a 2.8 million ASCs/cm3 injection or placebo in both submandibular glands and followed for minimally 2 years. The primary endpoint was number of serious adverse events (SAEs). Secondary endpoints included whole saliva flow rates and xerostomia-related symptoms. Data analysis was based on the intention-to-treat (ITT) population using repeated measures mixed-effects linear models. Results: Thirty-three patients were randomized; 30 patients were treated (ASC group, n=15; placebo group, n=15). Long-term safety data were collected from all 30 patients. During follow-up, 6/15 (40%) of the ASC-treated patients versus 5/15 (33%) of the placebo patients experienced an SAE; no SAEs appeared to be treatment-related. Unstimulated whole saliva flow rate increased to 0.20 and 0.16 mL/min in the ASC and placebo group, respectively, yielding a 0.05 mL/min (95% CI: 0.00 to 0.10, P=.051) difference between groups. Patient-reported xerostomia symptoms diminished according to a decreased Xerostomia Questionnaire summary score of 35.0 and 45.1, respectively (-10.1 [-18.1 to -2.2], P=.013). Three of the Visual Analog Scale xerostomia measures indicated clinical benefit following use of ASC. Conclusions:Our data show that ASC therapy is safe with a clinically relevant effect on xerostomia-related symptoms. Confirmation in larger randomized controlled trials is warranted.

clinical cancer research

Long-term Safety of Treatment with Autologous Mesenchymal Stem Cells in Patients with Radiation-Induced Xerostomia: Primary Results of the MESRIX Phase I/II Randomized Trial