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Stromal Vascular Fraction for Treatment of Xerostomia

NCT03061110 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-04-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Midwestern Regional Medical Center

    lead OTHER

Principal Investigators

  • Stephen Ray, MD · Midwestern Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-12-28
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061110 on ClinicalTrials.gov