drugset / Trial / NCT03061110
Stromal Vascular Fraction for Treatment of Xerostomia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rexlemestrocel-L | Cell therapy | — | Other |