Mesenchymal Stem Cells for Radiation-induced Xerostomia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Autologous Adipose-derived mesenchymal stem cells Autologous adipose-derived mesenchymal stem cells transplanted intraglandular in patients with radiation-induced hyposalivation and xerostomia |
Biological: Autologous adipose-derived mesenchymal stem/stromal cells
Autologous adipose-derived mesenchymal stem/stromal cells
|
| Placebo Comparator: Placebo 2 ml placebo: Isotonic NaCl (0.9mg(ml) and human albumin (HA) 1% |
Other: Placebo
Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1%
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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))
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial
-
Subjects who were treated with either autologous mesenchymal stem cells or placebo
-
Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial
Exclusion Criteria:
- Subjects who were not enrolled in the MESRIX trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Otolaryngology, University Hospital of Copenhagen | Copenhagen | Denmark |
Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
- Principal Investigator: Charlotte Lynggaard, MD, Department of Otolaryngology, Rigshospitalet, Copenhagen, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CVB2019-1
- 2014-004349-29