ABSTRACT
BACKGROUND: A predominant side effect of radiotherapy for head and neck cancer is salivary gland hypofunction and xerostomia leading to debilitating oral disorders and impaired quality of life (QoL). Intraglandular mesenchymal stem cell therapy has shown promising results as a treatment for xerostomia. METHODS: This is a randomised, double-blinded, placebo-controlled, parallel-group, prospective, single-centre trial investigating the safety, tolerability, and effectiveness of allogeneic stem cells as a treatment for radiation-induced hyposalivation and xerostomia for previous head and neck cancer patients. We will include a total of 120 patients who previously have been treated with radiotherapy for a head and neck cancer in Denmark. Participants will be randomly assigned using block randomisation to one of two parallel groups in a 1:1 ratio to receive ultrasound-guided injection of allogeneic adipose-derived mesenchymal stem cell (ASC) (n = 60) or placebo (n = 60) into the submandibular glands. Placebo will consist of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% dimethyl sulfoxide (DMSO). The primary endpoint is change in unstimulated whole saliva flow rate. The secondary endpoints are change in stimulated whole saliva flow rate, QoL, and composition of saliva. Further secondary endpoints are safety and immune response (human leukocyte antigen (HLA) response) to the stem cells will be assessed. Patients are evaluated at baseline (before treatment), after 4 months, and after 12 months. All study personnel, except study personnel thawing and preparing the treatment for injection, and participants will be blinded to group assignment. Unblinded study personnel will not participate in the outcome assessment. DISCUSSION: The trials will investigate the efficacy and safety of ASC injection to the submandibular gland as a potential new treatment for post-radiation xerostomia. We hope the results will pave the way for a clinically relevant treatment to ameliorate patients with xerostomia, a severely hampering condition. TRIAL REGISTRATION: The study is approved by the Danish Data Protection Agency (protocol number P-2020-1164), the National Ethics Committee protocol number: (Protocol number: 1802872), and the Danish Medical Agency (2018-000348-24). The protocol was registered at the ClinicalTrials.gov database (NCT04776538).
Subject(s)
Head and Neck Neoplasms , Mesenchymal Stem Cells , Xerostomia , Humans , Quality of Life , Prospective Studies , Xerostomia/etiology , Xerostomia/therapy , Head and Neck Neoplasms/radiotherapy , Randomized Controlled Trials as Topic , Clinical Trials, Phase II as TopicABSTRACT
A 28 year-old, previously healthy man was hospitalised with acute abdominal pain and a high fever. During six months the patient had suffered from severe pain in his left shoulder, left part of the thorax and over time also in the upper part of the abdomen. When hospitalised he showed biochemical signs of infection and a computer tomography of the abdomen revealed an 11 cm abscess in the spleen. Non-haemolytic streptococci were found after aspiration. Initially the abscess was treated with antibiotics and ultrasound-guided drainage. Due to lack of curative effect of drainage splenectomy was finally performed.