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The funding period for the study ended. The study did not reach full enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palatal Oral Mucosa (POM) Graft | Active Comparator | Standard of care palatal oral mucosa (POM) graft will be taken from the palate and then surgically placed onto the defect area |
|
| Ex vivo Produced Oral Mucosa Equivalent | Experimental | Palatal biopsy will be harvested for fabrication of autogenous ex vivo produced oral mucosa equivalent (EVPOME) and then surgically placed onto the defect area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVPOME (autogenous ex vivo produced oral mucosa equivalent) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Increase in Zone (Width) of Keratinized Mucosa at Grafted Site | The keratinized mucosa (KM) width will be measured by determining the distance from the crest of the edentulous ridge to the mucogingival line to the nearest millimeter with a Castroviejo caliper. The keratinized mucosa width of study subjects was measured prior to graft placement and then after two weeks, and after 4 weeks. The data provided shows the difference in keratinized mucosa width between the pre surgery measure and the post surgery measure. More mucosa width (positive numbers in mm) is an improvement, negative numbers (a decrease) would be less good. | 2 and 4 weeks post surgical graft |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Contracture | Graft measurements collected at each time point post graft surgery, 2 weeks, 4 weeks, 8 weeks and 24 weeks. Measurements collected, Horizontal Coronal (mm), Horizontal Apical (mm), Vertical between coronal and apical (mm), were used to determine the area of the graft as a trapezoid like shape. The area of the graft at each time point was compared to the area of the graft at the time of implantation (graft surgery) to determine the % of graft contracture from implantation thru each follow-up time point. Less graft contracture is considered a better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Blood Flow | Graft blood flow measured using Laser Doppler flowmetry (LDF) of the graft at 2 and 4 weeks after surgery. LDF measurements (perfusion units) are taken at the site of the graft and compared to LDF readings at a contralateral site on the same subject. The comparison is reported as a percent. The percent is derived by dividing the LDF perfusion units at the graft site by the LDF perfusion units at the contralateral site in the same subject. It is not known how many perfusion units are necessary to adequately supply blood to a graft. By comparing the graft site to the contralateral site in the same patient at 2 and 4 weeks post surgery this data may provide more understanding of graft incorporation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen E Feinberg, DDS, PhD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan, Department of Oral & Maxxillofacial Surgery | Ann Arbor | Michigan | 48109-5018 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 POM (Palatal oral mucosa): POM is a tissue graft harvested from the palate and surgically placed into the defect area |
| FG001 | 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Surgery to increase width of keratinized mucosa is clinically indicated or requested by the patient to facilitate oral hygiene procedures or to improve esthetics.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 POM (Palatal oral mucosa): POM is a tissue graft harvested from the palate and surgically placed into the defect area |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Increase in Zone (Width) of Keratinized Mucosa at Grafted Site | The keratinized mucosa (KM) width will be measured by determining the distance from the crest of the edentulous ridge to the mucogingival line to the nearest millimeter with a Castroviejo caliper. The keratinized mucosa width of study subjects was measured prior to graft placement and then after two weeks, and after 4 weeks. The data provided shows the difference in keratinized mucosa width between the pre surgery measure and the post surgery measure. More mucosa width (positive numbers in mm) is an improvement, negative numbers (a decrease) would be less good. | Pregraft data for this outcome was not collected for the first subject, the protocol was written to collect the pregraft measurement after the first subject completed POM graft. For this reason there are only 7 data points in the POM arm of the study. | Posted | Mean | Standard Deviation | millimeters | 2 and 4 weeks post surgical graft |
|
Life of study, 3 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 POM (Palatal oral mucosa): POM is a tissue graft harvested from the palate and surgically placed into the defect area |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen E. Feinberg | University of Michigan | 734 763 5963 | sefein@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2017 | May 21, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2019 | May 21, 2021 | ICF_001.pdf |
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| POM (Palatal oral mucosa) | Biological | POM is a tissue graft harvested from the palate and surgically placed into the defect area |
|
| 2, 4, 8 and 24 weeks after surgery |
| 2 and 4 weeks after surgery |
| Immunohistochemistry Using Anti-CD31 (Cluster of Differentiation 31) to Detect Blood Vessel Growth Into the Graft. | A biopsy of the graft is taken at 4 weeks after engraftment. The biopsy is stained for CD31 (cluster of differentiation 31) which is a marker for blood vessels. The number of blood vessels are counted in a standardized size of field. The number of blood vessels within the standardized field is reported. It is not known how much blood vessel development is necessary for graft success, but this study may provide insight into blood vessel development within EVPOME grafts over time. | 4 weeks after graft surgery |
| 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 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Deficient band of keratinized mucosa | Patients referred to clinic requiring surgery to increase width of keratinized mucosa as clinically indicated or requested by the patient to facilitate oral hygiene procedures or to improve esthetics were eligible to consent for a study screening visit. | Count of Participants | Participants |
|
Standard of care palatal oral mucosa (POM) graft will be taken from the palate and then surgically placed onto the defect area POM (Palatal oral mucosa): POM is a tissue graft harvested from the palate and surgically placed into the defect area |
| OG001 | 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 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. |
|
|
| Secondary | Graft Contracture | Graft measurements collected at each time point post graft surgery, 2 weeks, 4 weeks, 8 weeks and 24 weeks. Measurements collected, Horizontal Coronal (mm), Horizontal Apical (mm), Vertical between coronal and apical (mm), were used to determine the area of the graft as a trapezoid like shape. The area of the graft at each time point was compared to the area of the graft at the time of implantation (graft surgery) to determine the % of graft contracture from implantation thru each follow-up time point. Less graft contracture is considered a better outcome. | Posted | Mean | Standard Deviation | Percentage of graft contracture | 2, 4, 8 and 24 weeks after surgery |
|
|
|
| Other Pre-specified | Graft Blood Flow | Graft blood flow measured using Laser Doppler flowmetry (LDF) of the graft at 2 and 4 weeks after surgery. LDF measurements (perfusion units) are taken at the site of the graft and compared to LDF readings at a contralateral site on the same subject. The comparison is reported as a percent. The percent is derived by dividing the LDF perfusion units at the graft site by the LDF perfusion units at the contralateral site in the same subject. It is not known how many perfusion units are necessary to adequately supply blood to a graft. By comparing the graft site to the contralateral site in the same patient at 2 and 4 weeks post surgery this data may provide more understanding of graft incorporation. | Posted | Mean | Standard Deviation | Percent perfusion units graft/contralat | 2 and 4 weeks after surgery |
|
|
|
| Other Pre-specified | Immunohistochemistry Using Anti-CD31 (Cluster of Differentiation 31) to Detect Blood Vessel Growth Into the Graft. | A biopsy of the graft is taken at 4 weeks after engraftment. The biopsy is stained for CD31 (cluster of differentiation 31) which is a marker for blood vessels. The number of blood vessels are counted in a standardized size of field. The number of blood vessels within the standardized field is reported. It is not known how much blood vessel development is necessary for graft success, but this study may provide insight into blood vessel development within EVPOME grafts over time. | Posted | Mean | Standard Deviation | Number of blood vessels | 4 weeks after graft surgery |
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| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | 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 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. | 0 | 8 | 0 | 8 | 1 | 8 |
| Temporary numbness in throat due to anesthetic | General disorders | Systematic Assessment |
|
| Herpes Labialis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Severed Tendon Right Bicep | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bruising, neck | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Throbbing | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Sinus Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Keratin nodule | Skin and subcutaneous tissue disorders | Systematic Assessment | 1 mm punctate ulceration noted with small hard 'keratin'" nodule in buccal mucosa |
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| Stomach flu | Gastrointestinal disorders | Systematic Assessment |
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| Intra oral herpes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lack of energy with feeling of fever | General disorders | Systematic Assessment | Lack of energy with feeling of fever. |
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| 8 weeks post surgery |
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| 24 weeks post surgery |
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