Dry Mouth, Hyposalivation, Long Term Adverse Effects, Mesenchymal Stem Cells, Mesenchymal Stromal Cells, Radiation Toxicity, Xerostomia Due to Radiotherapy
Conditions
Keywords
Xerostomia Due to Radiotherapy
Brief 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.
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
Interventions
BIOLOGICALAutologous adipose-derived mesenchymal stem/stromal cells
Autologous adipose-derived mesenchymal stem/stromal cells
OTHERPlacebo
Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1%
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Long-term follow-up of Randomized controlled trial MESRIX
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Serious Adverse Events (SAEs) and new chronic diseases | 5 years from randomization | 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 |
| Overall survival | 5 years from randomization | 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 |
| Relapse of oropharyngeal cancer | 5 years from randomization | Number of participants with relapse will be reported |
| New malignancies | 5 years from randomization | Number of subjects who have new malignancies will be reported |
| Zoonotic Diseases | 5 years from randomization | Number of subjects diagnosed Zoonotic Diseases will be reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcome measures-Health-related quality of life (HRQoL | 5 years from randomization | 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)) |
Countries
Denmark
Outcome results
None listed