- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061110
Stromal Vascular Fraction for Treatment of Xerostomia
April 26, 2018 updated by: Stephen Ray, MD, Midwestern Regional Medical Center
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Zion, Illinois, United States, 60099
- Midwestern Regional Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care
Subjects in the Usual Care arm will receive typical therapies to manage the symptoms of dry mouth including but not limited to: chewing gum, sucking sugar-free candy, sipping water, mouth rinses and over-the-counter artificial saliva preparations.
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Usual care will include over-the-counter and prescription methods to treat xerostomia.
Other Names:
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Experimental: Stromal Vascular Fraction
Subjects in the Stromal Vascular Fraction arm will receive single injections into each of the six (6) peri-oral salivary glands (parotid, submandibular, sublingual).
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Stromal Vascular Fraction will be produced from the subject's own adipose tissue by the Tissue Genesis Icellator device.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Safety Profile (Reported Adverse Events graded according to CTCAE guidelines)
Time Frame: 72 hours
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Reported Adverse Events graded according to CTCAE guidelines will be recorded starting at or after the time of injection and at or before 72 hours post injection.
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72 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Months 3, 6 and 12 after Day 0 (date of injection)
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Unstimulated Saliva Production
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Rate of saliva production over a 5-minute period.
(g/minute)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Stimulated Saliva Production
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Rate of saliva production while chewing gum over a 5-minute period.
(g/minute)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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
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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)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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
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Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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)
|
Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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
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Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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
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Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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
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Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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
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Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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
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Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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
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Number of events as reported by patient (Number)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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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
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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)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have difficulties with speech because of the dry mouth?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = No problems; unchanged with respect to situation before radiation therapy; 2 = Occasionally some difficulty with speech; 3 = Frequently speech problems; 4 = always difficulties with speech; and 5= always major speech problems)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate speech?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = Never; 2 = Occasionally; 3 = Frequently; 4 = Always; and 5= Even have to interrupt speaking to take a sip of water)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Is swallowing changed because of the dry mouth problem?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = No problems; unchanged with respect to situation before radiation therapy; 2 = Occasionally some difficulty with swallowing; 3 = Frequently problems with swallowing; 4 = Always swallowing difficulties; and 5 = Swallowing is seriously impaired because of the dry mouth problem)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Has the dry mouth a negative influence on chewing?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = No change in chewing capability; 2 = Some difficulty with chewing; 3 = Frequently difficulties with chewing; 4 = Always difficulties with chewing; 5 = Chewing is seriously hampered because of the dry mouth problem)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate eating?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = No never; 2 = Sometimes, depending on the quality of the food; 3 = Frequently; more often than before radiation therapy; and 4 = Always need to take a sip of water/ fluid with every bite of food)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Did you change your feeding habits?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = No change; 2 = Minor changes, such as avoiding some products; 3 = Can eat only mashed food; 4 = Can eat only liquid food; and 5= Tube feeding)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have painful, dry, or crusted lips?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = Never; 2 = Sometimes, depending on the weather and environmental circumstances; 3 = Frequently; and 4 = Always, day and night)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to carry a bottle of fluid with you when leaving home?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = Never 2 = Occasionally; 3 = Frequently; 4 = Very often; and 5 = Always)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have a sore or painful mouth?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = Never 2 = Occasionally; 3 = Frequently; 4 = Very often; and 5 = Always)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Did your taste change?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = No change; normal taste sensation; 2 = Some reduction in taste discrimination and sensation; 3 = Considerable change in taste; 4 = No taste sensation at all; and 5 = Always a bad taste in the mouth)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Do you often have an infected oral mucosa or irritated gums?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - "Did your teeth deteriorate after radiation therapy?"
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1 = never; 2 = Occasionally; 3 = Frequently; and 4 = Very often)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Rotterdam Hospital Xerostomia Questionnaire - Overall Xerostomia Index
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Overall Xerostomia Index is calculated from the first three questions of the Questionnaire [I = (Q1 x 15.8) + (Q2 x 8.5) + (Q3 x 5.9) - 33.2; where Qn = score of that question.]
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Michigan Xerostomia-Related Quality of Life Scale - Physical Functioning
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 0=Best Functioning to 4=Worst Functioning)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Michigan Xerostomia-Related Quality of Life Scale - Pain/Discomfort
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 0=No Pain to 4=Worst Pain)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Michigan Xerostomia-Related Quality of Life Scale - Personal/Psychological Functioning
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 0=Best Functioning to 4=Worst Functioning)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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University of Michigan Xerostomia-Related Quality of Life Scale - Social Functioning
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score between Baseline and 3 months calculated from patient-reported survey (Likert Scale; 0=Best Functioning to 4=Worst Functioning)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Late Effects Normal Tissue-Subjective Objective Management Analytica (LENT-SOMA) survey
Time Frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Mean score calculated from patient-reported survey (Likert Scale; 1=Best Functioning to 4=Worst Functioning)
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Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephen Ray, MD, Midwestern Regional Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2018
Primary Completion (Anticipated)
December 28, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
February 17, 2017
First Submitted That Met QC Criteria
February 21, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
April 30, 2018
Last Update Submitted That Met QC Criteria
April 26, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MZ2017003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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