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

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

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.

Inclusion Criteria:

• Deficient band (<3mm) of keratinized mucosa prior to or following dental implant placement
• Surgery to increase width of keratinized mucosa is clinically indicated or requested by the patient to facilitate oral hygiene procedures or to improve esthetics
• Patients in need of a graft of approximately 15 x 10 x 20 mm in dimension

Exclusion Criteria:

• Subjects with potential medical complications such as evidence of clinically significant (as described by investigators) renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease which may complication execution of the protocol and/or interpretation of results
• Current radiation therapy or history of radiation therapy treatment to the intraoral donor biopsy site or recipient site for graft placement
• Documented history of syphilis, HIV, Hepatitis B or C virus
• Pregnant women or women planning to become pregnant or unwilling to abstain or use double barrier contraceptives during the course of the study
• Smoking or use of tobacco products within 6 months prior to screening
• History of either alcohol or drug abuse
• Subjects taking medications that can result in gingival enlargement/overgrowth (Cyclosporine, Dilantin, calcium channel blockers)
• Current use of intravenous bisphosphonate or current oral bisphosphate use or a history of bisphosphonate use for over 5 years