NCT01834326

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

A Randomized, Parallel-group Autogenous ex Vivo Produced Oral Mucosa Equivalent vs. Palatal Oral Mucosa Safety and Efficacy Study in Subjects Requiring Additional Keratinized Oral Mucosa for Dental Implants

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Stephen E. Feinberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study will test a tissue equivalent ex vivo produced oral mucosa equivalent(EVPOME), which is a subject's 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 that subject's 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. Each subject will be randomly assigned to receive either the EVPOME or POM to cover the defect in their mouth. 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.

Conditions

• Disorder of Oral Mucous Membrane

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-04-01
• Primary completion: 2019-01-15
• Completion: 2019-01-15
• First posted: 2013-04-17
• Last updated: 2021-09-05
• Results posted: 2021-09-05

Locations

1 site across 1 country: United States