Mesenchymal Stem Cells for Radiation-induced Xerostomia

Radiation Toxicity Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03876197
• Other study ID #: CVB2019-1
• Secondary ID: 2014-004349-29
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: August 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Autologous adipose-derived mesenchymal stem/stromal cells
Autologous adipose-derived mesenchymal stem/stromal cells

Other:
• Placebo
Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1%

Locations

Country	Name	City	State
Denmark	Department of Otolaryngology, University Hospital of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Relapse of oropharyngeal cancer	Number of participants with relapse will be reported	5 years from randomization
Primary	New malignancies	Number of subjects who have new malignancies will be reported	5 years from randomization
Primary	Zoonotic Diseases	Number of subjects diagnosed Zoonotic Diseases will be reported	5 years from randomization
Secondary	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