NCT03061110

Stromal Vascular Fraction for Treatment of Xerostomia

Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System® ("Icellator") Autologous Adipose Stromal Vascular Fraction Cells as a Treatment for Post-Irradiated Induced Xerostomia in Head and Neck Cancer Patients

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Midwestern Regional Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Xerostomia Due to Radiotherapy (Disorder)

Interventions

Type	Name	Description
BIOLOGICAL	Stromal Vascular Fraction	Stromal Vascular Fraction will be produced from the subject's own adipose tissue by the Tissue Genesis Icellator device.
OTHER	Usual Care	Usual care will include over-the-counter and prescription methods to treat xerostomia.

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-12-28
• Completion: 2020-12-31
• First posted: 2017-02-23
• Last updated: 2018-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study