Stromal Vascular Fraction for Treatment of Xerostomia
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Xerostomia Due to Radiotherapy (Disorder)
In brief
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.
Key facts
- Study ID
- NCT03061110
- Run by
- Midwestern Regional Medical Center
- People needed
- 0
- Starts
- 2018-11-01
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2018-04-30
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Midwestern Regional Medical Center — Zion, Illinois, United States
Full record on ClinicalTrials.gov
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