Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System® ("Icellator") Autologous Adipose Stromal Vascular Fraction Cells as a Treatment for Post-Irradiated Induced Xerostomia in Head and Neck Cancer Patients

简要总结

主要结局

次要结局

• Chronic Safety Profile (Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines)(Months 3, 6 and 12 after Day 0 (date of injection))
• Unstimulated Saliva Production(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• Stimulated Saliva Production(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In the open air)(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In the open air in case of wind and cold)(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In air-conditioned spaces)(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth during daytime)(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth at nighttime)(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Always dry mouth night and day)(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially bother of the dry mouth during meals)(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire- "How often do you wake up at night because of a dry mouth?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "How would you describe the quality of your saliva?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire- "How severe is your dry mouth problem?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have difficulties with speech because of the dry mouth?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate speech?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Is swallowing changed because of the dry mouth problem?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Has the dry mouth a negative influence on chewing?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate eating?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Did you change your feeding habits?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have painful, dry, or crusted lips?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to carry a bottle of fluid with you when leaving home?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have a sore or painful mouth?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Did your taste change?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Do you often have an infected oral mucosa or irritated gums?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Did your teeth deteriorate after radiation therapy?"(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Rotterdam Hospital Xerostomia Questionnaire - Overall Xerostomia Index(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Michigan Xerostomia-Related Quality of Life Scale - Physical Functioning(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Michigan Xerostomia-Related Quality of Life Scale - Pain/Discomfort(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Michigan Xerostomia-Related Quality of Life Scale - Personal/Psychological Functioning(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• University of Michigan Xerostomia-Related Quality of Life Scale - Social Functioning(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)
• Late Effects Normal Tissue-Subjective Objective Management Analytica (LENT-SOMA) survey(Assessed at Baseline and 3 months, 6 months and 12 months after Baseline)