drugset / Trial / NCT03061110

Stromal Vascular Fraction for Treatment of Xerostomia

NCT03061110

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-11-01
Primary completion
2020-12-28
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Rexlemestrocel-L Cell therapy Other