Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa (2012-2016)

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Funded by Department of Defense - Department of the Army

Funding Years: 2012-2016

This study will test a tissue equivalent ex vivo produced oral mucosa equivalent (EVPOME), which is your own cells grown on top of a piece of AlloDerm (a commercially available freeze dried human cadaver tissue that is routinely used in present day surgical reconstructive procedures) to create a new piece of soft tissue for use only in your body. The tissue equivalent product will be tested against a non-experimental method of grafts, the gold standard a piece of palatal oral mucosa (POM) to see which works best. Patients will be randomly assigned to receive either the EVPOME or POM to cover the defect in their mouths. The objective of the study is to assess the safety and efficacy for the use of human EVPOME for soft tissue intraoral grafting procedures compared to the "gold standard" palatal oral mucosa (POM) graft.

PI(s): Stephen Feinberg, Robert Eber

Co-I(s): H. Myra Kim, William Giannobile