Clinical trial NCT03876197: Mesenchymal Stem Cells for Radiation-induced Xerostomia
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Radiation Toxicity
Xerostomia Due to Radiotherapy
Dry Mouth
Hyposalivation
Mesenchymal Stem Cells
Mesenchymal Stromal Cells
Long Term Adverse Effects
Keywords: Xerostomia Due to Radiotherapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Long-term follow-up of Randomized controlled trial MESRIX
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Safety: Serious Adverse Events (SAEs) and new chronic diseases
timeFrame: 5 years from randomization
measure: Overall survival
timeFrame: 5 years from randomization
measure: Relapse of oropharyngeal cancer
timeFrame: 5 years from randomization
measure: New malignancies
timeFrame: 5 years from randomization
measure: Zoonotic Diseases
timeFrame: 5 years from randomization
Secondary outcomes:
measure: Patient-reported outcome measures-Health-related quality of life (HRQoL
timeFrame: 5 years from randomization
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Otolaryngology, University Hospital of Copenhagen
Study officials:
affiliation: Department of Otolaryngology, Rigshospitalet, Copenhagen, Denmark
name: Charlotte Lynggaard, MD
role: PRINCIPAL_INVESTIGATOR
References: