Mesenchymal Stem Cells for Radiation-induced Xerostomia

Status Enrolling by invitation

Clinical Trial Summary

A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX.

Clinical Trial Description

This is a LTFU study to assess the long-term and late effects of treatment with MSCs or placebo given ultrasound-guided into the submandibular glands in subjects participating in the MESRIX trial. Study participants from the MESRIX trial will be invited for a clinical visit. The visit will include medical history, an ENT examination; measurements of the saliva production by sialometry, a Magnetic resonance imaging scan (MRI) and obtaining data on the patient-reported outcome with Xerostomia Questionnaire (XQ) and Visual-Analogue-Symptomatic scale (VAS). Subjects, who are not able or willing to attend a clinical visit, will be encouraged to fill out the Questionnaires online or on paper. If a study participant has deceased, information of the cause of death will be investigated in The Danish Register of Causes of Death ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03876197
Study type	Interventional
Source	Rigshospitalet, Denmark
Contact
Status	Enrolling by invitation
Phase	Phase 1/Phase 2
Start date	August 1, 2020
Completion date	December 1, 2023

View Details

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