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

NCT ID: NCT01834326

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2019-01-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Palatal Oral Mucosa (POM) Graft

Standard of care palatal oral mucosa (POM) graft will be taken from the palate and then surgically placed onto the defect area

Group Type: ACTIVE_COMPARATOR

POM (Palatal oral mucosa)

Intervention Type: BIOLOGICAL

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

Ex vivo Produced Oral Mucosa Equivalent

Palatal biopsy will be harvested for fabrication of autogenous ex vivo produced oral mucosa equivalent (EVPOME) and then surgically placed onto the defect area

Group Type: EXPERIMENTAL

EVPOME (autogenous ex vivo produced oral mucosa equivalent)

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: BIOLOGICAL

POM (Palatal oral mucosa)

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stephen E. Feinberg

OTHER

Sponsor Role: lead

Responsible Party

Stephen E. Feinberg

Professor & Associate Chair of Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephen E Feinberg, DDS, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan, Department of Oral & Maxxillofacial Surgery

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00065554

Identifier Type: -

Identifier Source: org_study_id