Mesenchymal Stem Cells for Radiation-induced Xerostomia

Follow-up Study of Safety and Efficacy in Subjects Who Participated in the Study of Intraglandular Mesenchymal Stem Cells in Patients With Radiation-induced Hyposalivation and Xerostomia (MESRIX)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Department of Otolaryngology, University Hospital of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Autologous Adipose-derived mesenchymal stem cells; Autologous adipose-derived mesenchymal stem cells transplanted intraglandular in patients with radiation-induced hyposalivation and xerostomia	Biological: Autologous adipose-derived mesenchymal stem/stromal cells; Autologous adipose-derived mesenchymal stem/stromal cells
PLACEBO_COMPARATOR: Placebo; 2 ml placebo: Isotonic NaCl (0.9mg(ml) and human albumin (HA) 1%	Other: Placebo; Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Serious Adverse Events (SAEs) and new chronic diseases	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	5 years from randomization
Overall survival	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	5 years from randomization
Relapse of oropharyngeal cancer	Number of participants with relapse will be reported	5 years from randomization
New malignancies	Number of subjects who have new malignancies will be reported	5 years from randomization
Zoonotic Diseases	Number of subjects diagnosed Zoonotic Diseases will be reported	5 years from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported outcome measures-Health-related quality of life (HRQoL	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))	5 years from randomization

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Charlotte Lynggaard, MD, Department of Otolaryngology, Rigshospitalet, Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (ACTUAL): March 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Xerostomia Due to Radiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia; Long Term Adverse Effects
• Other Study ID Numbers: CVB2019-1; 2014-004349-29 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No