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

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)

Study Overview

• Status: Completed
• Conditions: Interdental Papillary Insufficiency
• Intervention / Treatment: Biological: Autologous Human Fibroblasts (azficel-T)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77063
      • Perio-Health Professionals, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Castle Creek Biosciences, LLC.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (Estimate): April 10, 2008

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IT-G-003