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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
30
Autologous adipose-derived mesenchymal stem/stromal cells
Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1%
Department of Otolaryngology, University Hospital of Copenhagen
Copenhagen, Denmark
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
Time frame: 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
Time frame: 5 years from randomization
Relapse of oropharyngeal cancer
Number of participants with relapse will be reported
Time frame: 5 years from randomization
New malignancies
Number of subjects who have new malignancies will be reported
Time frame: 5 years from randomization
Zoonotic Diseases
Number of subjects diagnosed Zoonotic Diseases will be reported
Time frame: 5 years from randomization
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))
Time frame: 5 years from randomization
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