Clinical trial NCT03061110: Stromal Vascular Fraction for Treatment of Xerostomia
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 Induced Xerostomia in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Xerostomia Due to Radiotherapy (Disorder)
Lead sponsor: Midwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to usual care (palliation of symptoms) or injection of stromal vascular fraction.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Male and Female subjects are both eligible
* Subjects must be 21 years of age or older
* History of treated Head and Neck Cancer, no evidence of active cancer at the time of the study
* Original tumor not located adjacent to the parotid or sub-mandibular glands
* Diagnosis of radiation-induced xerostomia
* study is fully explained
* Females of child bearing potential agree to use acceptable methods of contraception through 6 month study follow-up.
* No current malignancy or history of previous malignancy within the last five years, other than the head and neck cancer, with the exception of adequately treated non-abdominal, non-melanoma cutaneous carcinoma (basal cell or squamous cell carcinoma of the skin)
* Willing to undergo a minor surgical procedure (small-volume liposuction, totaling approximately 60-120cc) and a single treatment of an injection of approximately 30ml of autologous Stromal Vascular Fraction taking approximately 10 minutes
* Abdominal area amenable to liposuction of at least 60-120cc of adipose tissue based on Investigator(s) examination
* Willing to be available for all baseline, treatment and follow-up examinations required by protocol
* Willing to forego participation in any other study throughout the duration of this study unless receiving prior approval by Investigator

Exclusion Criteria:

* Patients taking immunosuppressive therapy in the prior 3 months
* Autoimmune disorders
* Patients who are pregnant or currently breast-feeding children
* Patients participating in a study of an experimental drug or medical device within 60 days of study entry
* Uncontrolled hypertension
* Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening
* Hemoglobin A1c \> 8% within 8 weeks prior to study treatment
* Current use of steroids or immunosuppressant therapies
* Any other condition, which, in the opinion of the Investigator, would contraindicate treatment, affect compliance, interfere with study evaluations, limit study participation, or confound the interpretation of study results
* History of Sjogren's Syndrome or related autoimmune disease.
* Taking medication for which xerostomia is a known major side effect

Primary outcomes:
measure: Acute Safety Profile (Reported Adverse Events graded according to CTCAE guidelines)
timeFrame: 72 hours
Secondary outcomes:
measure: Chronic Safety Profile (Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines)
timeFrame: Months 3, 6 and 12 after Day 0 (date of injection)
measure: Unstimulated Saliva Production
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: Stimulated Saliva Production
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire- "How severe is your dry mouth problem?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In the open air)
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: 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)
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In air-conditioned spaces)
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth during daytime)
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth at nighttime)
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Always dry mouth night and day)
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially bother of the dry mouth during meals)
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire- "How often do you wake up at night because of a dry mouth?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "How would you describe the quality of your saliva?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have difficulties with speech because of the dry mouth?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate speech?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Is swallowing changed because of the dry mouth problem?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Has the dry mouth a negative influence on chewing?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate eating?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Did you change your feeding habits?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have painful, dry, or crusted lips?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to carry a bottle of fluid with you when leaving home?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have a sore or painful mouth?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Did your taste change?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Do you often have an infected oral mucosa or irritated gums?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - "Did your teeth deteriorate after radiation therapy?"
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Rotterdam Hospital Xerostomia Questionnaire - Overall Xerostomia Index
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Michigan Xerostomia-Related Quality of Life Scale - Physical Functioning
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Michigan Xerostomia-Related Quality of Life Scale - Pain/Discomfort
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Michigan Xerostomia-Related Quality of Life Scale - Personal/Psychological Functioning
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: University of Michigan Xerostomia-Related Quality of Life Scale - Social Functioning
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
measure: Late Effects Normal Tissue-Subjective Objective Management Analytica (LENT-SOMA) survey
timeFrame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
Other outcomes:
Locations:
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
Study officials:
affiliation: Midwestern Regional Medical Center
name: Stephen Ray, MD
role: PRINCIPAL_INVESTIGATOR
References: