Mesenchymal Stem Cells for Radiation-induced Xerostomia

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Radiation Toxicity, Xerostomia Due to Radiotherapy, Dry Mouth, Hyposalivation, Mesenchymal Stem Cells, Mesenchymal Stromal Cells, Long Term Adverse Effects

Intervention / Treatment
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* Biological: Autologous adipose-derived mesenchymal stem/stromal cells
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial Subjects who were treated with either autologous mesenchymal stem cells or placebo 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Long-term follow-up of Randomized controlled trial MESRIX
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xerostomia Due to Radiotherapy