Trial reportTrials2017
First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial.
Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02513238 (Mesenchymal Stem Cells for Radiation-induced Xerostomia), which is not on this map. Cited by 26 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Mesenchymal Stem Cells for Radiation-induced Xerostomia (MESRIX) in Previous HPV-positive Oropharyngeal Head and Neck Cancer Patients - A Safety and Feasibility Study
Who cites it
26 citing papers in PubMed, 64 citations in OpenAlex.
- Development-inspired approach for the derivation of functional and transplantable salivary gland organoids from human pluripotent stem cells.Nature communications · 2026Article
- Effect of locally transplanted bone marrow derived mesenchymal stem cells on the lingual filiform and fungiform papillae of ovariectomized albino rat model.BMC oral health · 2026Article
- First-in-human study to investigate the safety and efficacy of effective-mononuclear cell therapy for radiogenic xerostomia.Regenerative therapy · 2026Article
- Radiation-Induced Fibrosis (RIF) in Head and Neck Squamous Cell Carcinoma (HNSCC): A Review.Cells · 2025Review
- Radiation-Therapy Related Salivary Dysfunction.Seminars in radiation oncology · 2025Review
- Ferroptosis: a double-edged sword that enhances radiation sensitivity and facilitates radiation-induced injury in tumors.Frontiers in immunology · 2025Review
- Cancer therapy-related salivary dysfunction.The Journal of clinical investigation · 2024Review
- Long-Term Outcome Following Treatment With Allogeneic Mesenchymal Stem/Stromal Cells for Radiation-Induced Hyposalivation and Xerostomia.Stem cells translational medicine · 2024Article
- Advances in Regenerative Dentistry Approaches: An Update.International dental journal · 2024Review
- Salivary Gland Bioengineering.Bioengineering (Basel, Switzerland) · 2023Review
- Tissue fibrosis induced by radiotherapy: current understanding of the molecular mechanisms, diagnosis and therapeutic advances.Journal of translational medicine · 2023Review
- Article
- Autologous mesenchymal stem cells offer a new paradigm for salivary gland regeneration.International journal of oral science · 2023Review
- Cell-Free Therapies: The Use of Cell Extracts to Mitigate Irradiation-Injured Salivary Glands.Biology · 2023Review
- Salivary gland function, development, and regeneration.Physiological reviews · 2022Review
- Bioengineering in salivary gland regeneration.Journal of biomedical science · 2022Review
- Application of regenerative medicine to salivary gland hypofunction.The Japanese dental science review · 2021Review
- Late Central Airway Toxicity after High-Dose Radiotherapy: Clinical Outcomes and a Proposed Bronchoscopic Classification.Cancers · 2021Article
- Regenerative Medicine of Epithelia: Lessons From the Past and Future Goals.Frontiers in bioengineering and biotechnology · 2021Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSalivary 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.
methodsThis 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 registrationEudraCT, Identifier: 2014-004349-29. Registered on 1 April 2015. ClinicalTrials.gov, Identifier: NCT02513238 . First received on 2 July 2015. The trial is prospectively registered.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.