Exploring the salivary proteome following intraglandular mesenchymal stromal cell therapy for radiation-induced hyposalivation in previous head and neck cancer patients: a secondary study protocol for the MESRIX-III, ran
Carlander AF., Jakobsen KK., Jersie-Christensen R., Hansen J., Bendtsen SK., Kastrup J.
Randomized Controlled Trial with a reported sample of 120, published in Trials (2025) — summary generated from the PubMed abstract.
Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Randomized Controlled Trial
- Journal
- Trials (2025)
- Country
- England
- Reported sample size
- 120
- Source database
- PubMed
- PMID
- 41316394
- PMCID
- PMC12664238
- DOI
- 10.1186/s13063-025-09074-4
- NCT
- NCT04776538
Abstract (original English)
Background Intraglandular therapy with adipose-derived mesenchymal stromal cells (ASCs) for radiation-induced xerostomia and hyposalivation has shown promising effects on the salivary flow rate and in patient-reported outcomes. However, the mode of action is not fully understood, but changes in the salivary proteome have been observed. Methods This sub study, to the randomised, double-blinded, placebo-controlled trial investigating intraglandular mesenchymal stromal cells for radiation-induced hyposalivation (MESRIX-III), examines changes in the salivary proteome following intraglandular therapy into the submandibular glands with allogenic ASCs in unstimulated whole saliva (UWS) in previous head and neck cancer patients with radiation-induced hyposalivation. A total of 120 patients were included and randomised in a 1:1 ratio to receive intraglandular injections with either ASCs or placebo (CryoStor10, 10% dimethyl sulfoxide, Biolife Solutions). UWS samples was collected at baseline and at 4 months post transplantation. The main endpoint is comparison of the salivary human proteome evaluated by mass spectrometry analysis in the group receiving ASCs compared to placebo at 4 months. Secondary outcomes are comparison of the microbial proteome in the group receiving ASCs compared to placebo at 4 months; changes in the salivary proteome and microbial proteome in the group receiving A
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.
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