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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Christian Grønhøj, David H. Jensen, Peter V. Glovinski, Siri Beier Jensen, Allan Bardow, Roberto S. Oliveri, Lena Specht, Carsten Thomsen, Sune Darkner, Katalin Kiss, Anne Fischer-Nielsen, Christian von Buchwald
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1856-0) contains supplementary material, which is available to authorized users.

Abstract

Background

Salivary gland hypofunction and xerostomia are major complications following radiotherapy for head and neck cancer and may lead to debilitating oral disorders and impaired quality of life. Currently, only symptomatic treatment is available. However, mesenchymal stem cell (MSC) therapy has shown promising results in preclinical studies. Objectives are to assess safety and efficacy in a first-in-man trial on adipose-derived MSC therapy (ASC) for radiation-induced xerostomia.

Methods

This is a single-center, phase I/II, randomized, placebo-controlled, double-blinded clinical trial. A total of 30 patients are randomized in a 1:1 ratio to receive ultrasound-guided, administered ASC or placebo to the submandibular glands. The primary outcome is change in unstimulated whole salivary flow rate. The secondary outcomes are safety, efficacy, change in quality of life, qualitative and quantitative measurements of saliva, as well as submandibular gland size, vascularization, fibrosis, and secretory tissue evaluation based on contrast-induced magnetic resonance imaging (MRI) and core-needle samples. The assessments are performed at baseline (1 month prior to treatment) and 1 and 4 months following investigational intervention.

Discussion

The trial is the first attempt to evaluate the safety and efficacy of adipose-derived MSCs (ASCs) in patients with radiation-induced xerostomia. The results may provide evidence for the effectiveness of ASC in patients with salivary gland hypofunction and xerostomia and deliver valuable information for the design of subsequent trials.

Trial registration

EudraCT, Identifier: 2014-004349-29. Registered on 1 April 2015.
ClinicalTrials.gov, Identifier: NCT02513238. First received on 2 July 2015.
The trial is prospectively registered.
Zusatzmaterial
Additional file 1: SPIRIT Checklist. (DOC 121 kb)
13063_2017_1856_MOESM1_ESM.doc
Literatur
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