Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Safety and Efficacy of Mesenchymal Stem Cells for Radiation-Induced Xerostomia: A Randomized, Placebo-Controlled Phase 1/2 Trial (MESRIX)

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Lymphoblastic Lymphoma: Guidelines From the International Lymphoma Radiation Oncology Group (ILROG)

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

  1. Dynamic soft tissue changes in the orbit after a blowout fracture

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. PET/CT prior to salvage surgery in recurrent head and neck squamous cell carcinoma

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Reliability and validity of The Danish pediatric voice handicap index

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Only minor stem cell mobilization in head and neck irradiated patients treated with hyperbaric oxygen

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. High-Throughput Sequencing-Based Investigation of Viruses in Human Cancers by Multienrichment Approach

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

BACKGROUND: Salivary gland hypofunction and xerostomia are major complications to head and neck radiotherapy. This trial assessed the safety and efficacy of adipose tissue-derived mesenchymal stem cell (ASC) therapy for radiation-induced xerostomia.

PATIENT AND METHODS: This randomized, placebo-controlled phase 1/2 trial included 30 patients, randomized in a 1:1 ratio to receive ultrasound-guided transplantation of ASCs or placebo to the submandibular glands. Patients had previously received radiotherapy for a T1-2, N0-2A, human papillomavirus-positive, oropharyngeal squamous cell carcinoma. The primary outcome was the change in unstimulated whole salivary flow rate, measured before and after the intervention. All assessments were performed one month prior (baseline) and one and four months following ASC or placebo administration.

RESULTS: No adverse events were detected. Unstimulated whole salivary flow rates significantly increased in the ASC-arm at one (33%; P = .048) and four months (50%; P = .003), but not in the placebo-arm (P = .6 and P = .8), compared to baseline. The ASC-arm symptom scores significantly decreased on the xerostomia and VAS questionnaires, in the domains of thirst (-22%, P = .035) and difficulties in eating solid foods (-2%, P = .008) after four months compared to baseline. The ASC-arm showed significantly improved salivary gland functions of inorganic element secretion and absorption, at baseline and four months, compared to the placebo-arm. Core-needle biopsies showed increases in serous gland tissue and decreases in adipose and connective tissues in the ASC-arm compared to the placebo-arm (P = .04 and P = .02, respectively). MRIs showed no significant differences between groups in gland size or intensity (P < .05).

CONCLUSIONS: ASC therapy for radiation-induced hypofunction and xerostomia was safe and significantly improved salivary gland functions and patient-reported outcomes. These results should encourage further exploratory and confirmatory trials.

OriginalsprogEngelsk
TidsskriftInternational Journal of Radiation Oncology Biology Physics
Vol/bind101
Udgave nummer3
Sider (fra-til)581-592
Antal sider12
ISSN0360-3016
DOI
StatusUdgivet - 1 jul. 2018

ID: 55218303