Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM in subjects with maxillary lesions who were treated in a previous study (IT-G-002, no NCT identification number)

Conditions
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Interdental Papillary Insufficiency

Intervention / Treatment
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* Biological: Autologous Human Fibroblasts (azficel-T)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be 18-70 years of age Subject was treated in IT-G-002 (no NCT identification number) Subject has maxillary interproximal recession defects Natural teeth must be present on both sides of each area to be treated Negative pregnancy test and use of acceptable birth control (females of childbearing age) Exclusion Criteria: Subjects who participated in other clinical trials within 30 days prior to enrollment Interproximal spaces including root grooves or furcations must not be involved Subjects with poor oral hygiene Subjects with a systemic condition, which would preclude periodontal treatment Subjects with acute infectious lesions in the treatment areas Subjects with open interproximal contact at study sites Subjects who must receive prophylactic antibiotics before dental procedures Subjects on chronic antibiotic or steroidal therapy Subjects with interproximal probing depths > 3 mm around study lesions Subjects who smoke Subjects taking medications associated with the development of drug induced gingival hyperplasia Subjects with radiographic evidence of pathology Subjects with tooth mobility exceeding a score of 1 Subjects with parafunctional habits and not wearing bite guard Subjects with interproximal spaces associated with teeth without an adequate zone of keratinized tissue Subjects where the etiology of the interproximal papillary recession has not been controlled Subjects who have received a crown or pontic on one or both teeth involved in the interproximal space to be treated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Biological: Autologous Human Fibroblasts (azficel-T)<br>* Collection of biopsy from palate Papillary priming procedure Seven injection treatments to target sites Performance of study assessments (investigator and subject)<br>* Other names: LAVIV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) | A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best. | Baseline (prior to first study treatment) compared to six months after first treatment | 
| Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) | A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best. | Baseline (prior to first study treatment) compared to six months after first treatment |