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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
First received
Last updated
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
Health authority
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

Study Design


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
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