Mesenchymal Stem Cells for Radiation-induced Xerostomia

Phase 1

• Conditions: Dry Mouth; Mesenchymal Stem Cells; Radiation Toxicity; Xerostomia Due to Radiotherapy; Hyposalivation; Long Term Adverse Effects; Mesenchymal Stromal Cells
• Interventions: Biological: Autologous adipose-derived mesenchymal stem/stromal cells; Other: Placebo

• Registration Number: NCT03876197
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Study Start: 2020-08-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial
2. Subjects who were treated with either autologous mesenchymal stem cells or placebo
3. Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial

Exclusion Criteria

1. Subjects who were not enrolled in the MESRIX trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Adipose-derived mesenchymal stem cells	Autologous adipose-derived mesenchymal stem/stromal cells	Autologous adipose-derived mesenchymal stem cells transplanted intraglandular in patients with radiation-induced hyposalivation and xerostomia
Placebo	Placebo	2 ml placebo: Isotonic NaCl (0.9mg(ml) and human albumin (HA) 1%

Primary Outcome Measures

Name	Time	Method
Relapse of oropharyngeal cancer	5 years from randomization	Number of participants with relapse will be reported
Safety: Serious Adverse Events (SAEs) and new chronic diseases	5 years from randomization	SAEs according to the ICH-GCP definition and new chronic diseases. For patients not attending the planned hospital visit consider searching The National Patient Register will be searched for registered SAEs. Number of patients
New malignancies	5 years from randomization	Number of subjects who have new malignancies will be reported
Zoonotic Diseases	5 years from randomization	Number of subjects diagnosed Zoonotic Diseases will be reported
Overall survival	5 years from randomization	Overall survival is defined as the time from the intraglandular dose of the investigational product (MSCs or placebo) to the date of death or the date the subject is last known to be alive

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcome measures-Health-related quality of life (HRQoL	5 years from randomization	Xerostomia Questionnaire (XQ) ( Median item scores for each of the 8 questions will be reported (score range 0-10) and the XQ summary/composite score (0-100))

Trial Locations

Locations (1)

Department of Otolaryngology, University Hospital of Copenhagen; 🇩🇰 Copenhagen, Denmark