drugset / Trial / NCT01834339

EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

NCT01834339 ↗

Phase 2 Terminated 1 enrolled Stephen E. Feinberg
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.

Timeline

Start
2013-09
Primary completion
2014-11
Completion
2015-12

Outcome

Outcome not reported

Stopped: “Loss of cGMP facility to manufacture product used in clinical trial.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator AlloDerm Other / unclassified — —
Subject EVPOME Unknown — —

Indications

No indication recorded.