Clinical Trial: Stromal Vascular Fraction for Treatment of Xerostomia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 In

Brief Summary: Prospective, single center, double armed, randomized treatment with observation only (standard of care) control group. Subjects receiving study treatment will have 6 months of study follow-up. Stromal vascular fraction (SVF), an adipose-derived tissue preparation, will be injected into salivary glands to determine safety and efficacy to restore saliva production in head and neck cancer patients with chronic xerostomia resulting from radiation therapy.

Detailed Summary:
Sponsor: Midwestern Regional Medical Center

Current Primary Outcome: Acute Safety Profile (Reported Adverse Events graded according to CTCAE guidelines) [ Time Frame: 72 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Chronic Safety Profile (Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines) [ Time Frame: Months 3, 6 and 12 after Day 0 (date of injection) ]
  Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines will be recorded starting on Day 0 (day of SVF injection) and ending at 12 months.
• Unstimulated Saliva Production [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Rate of saliva production over a 5-minute period. (g/minute)
• Stimulated Saliva Production [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Rate of saliva production while chewing gum over a 5-minute period. (g/minute)
• University of Rotterdam Hospital Xerostomia Questionnaire- "How severe is your dry mouth problem?" [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Mean score calculated from patient-reported survey (Likert Scale; 1 = Normal; 2 = somewhat more complaints than before radiation therapy; 3 = considerable more complaints than before radiation therapy; and 4 = Permanent complaints of a very dry mouth)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In the open air) [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
• 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) [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In air-conditioned spaces) [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth during daytime) [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth at nighttime) [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Always dry mouth night and day) [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially bother of the dry mouth during meals) [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
• University of Rotterdam Hospital Xerostomia Questionnaire- "How often do you wake up at night because of a dry mouth?" [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Number of events as reported by patient (Number)
• University of Rotterdam Hospital Xerostomia Questionnaire - "How would you describe the quality of your saliva?" [ Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline ]
  Mean score calculated from patient-reported survey (Likert Scale; 1 = Normal, watery fluid; 2 = Normal watery but too little volume; 3 = Sticky saliva; and 4 = No saliva at all)
• University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have difficulties with speech because of the dry mouth?" [ Time Frame: Assessed at Baseline and 3 mon
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Midwestern Regional Medical Center
  

  Dates:
  Date Received: February 17, 2017
  Date Started: May 1, 2017
  Date Completion: May 31, 2019
  Last Updated: March 8, 2017
  Last Verified: March 2017