Stromal Vascular Fraction for Treatment of Xerostomia (NCT03061110) | Clinical Trial Compass
WithdrawnPhase 1/2
Stromal Vascular Fraction for Treatment of Xerostomia
Stopped: Internal funding not awarded.
United States0Started 2018-11-01
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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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-fee…
What they're measuring
1
Acute Safety Profile (Reported Adverse Events graded according to CTCAE guidelines)