Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2018-11-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Usual Care
Usual care will include over-the-counter and prescription methods to treat xerostomia.
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).
Stromal Vascular Fraction
Stromal Vascular Fraction will be produced from the subject's own adipose tissue by the Tissue Genesis Icellator device.
Interventions
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Stromal Vascular Fraction
Stromal Vascular Fraction will be produced from the subject's own adipose tissue by the Tissue Genesis Icellator device.
Usual Care
Usual care will include over-the-counter and prescription methods to treat xerostomia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Midwestern Regional Medical Center
OTHER
Responsible Party
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Stephen Ray, MD
Surgeon
Principal Investigators
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Stephen Ray, MD
Role: PRINCIPAL_INVESTIGATOR
Midwestern Regional Medical Center
Locations
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Midwestern Regional Medical Center
Zion, Illinois, United States
Countries
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Other Identifiers
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MZ2017003
Identifier Type: -
Identifier Source: org_study_id