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Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa

NCT01834326 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-09-05

Study results available
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Summary

The purpose of this study is to improve the current standard of care of repairing mouth soft tissue defects.

Conditions

  • Disorder of Oral Mucous Membrane

Interventions

BIOLOGICAL

EVPOME (autogenous ex vivo produced oral mucosa equivalent)

EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process.

BIOLOGICAL

POM (Palatal oral mucosa)

POM is a tissue graft harvested from the palate and surgically placed into the defect area

Sponsors & Collaborators

  • Stephen E. Feinberg

    lead OTHER

Principal Investigators

  • Stephen E Feinberg, DDS, PhD, MS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2019-01-15
Completion
2019-01-15

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 NCT01834326 on ClinicalTrials.gov