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

NCT00655889 | Completed Phase 2 Results

• 1 other identifier: IT-G-003
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Interdental Papillary Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Active

EXPERIMENTAL

Biological: Autologous Human Fibroblasts (azficel-T)

Interventions

Autologous Human Fibroblasts (azficel-T) BIOLOGICAL

1. Collection of biopsy from palate 2. Papillary priming procedure 3. Seven injection treatments to target sites 4. Performance of study assessments (investigator and subject)

Also known as: LAVIV

Active

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Castle Creek Biosciences, LLC.: lead

Study Sites (1)

Perio-Health Professionals, Inc.

Houston, Texas, 77063, United States

Location

Limitations and Caveats

This was a small, open-label study without a placebo control, and was not powered to provide statistically significant demonstrations of product efficacy.

Results Point of Contact

• Title: Dr. Joseph Fratantoni
• Organization: Biologics Consulting Group

jfratantoni@bcg-usa.com

(301) 340-8432

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: January 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 23, 2021
• Results First Posted: August 15, 2013

Record last verified: 2021-03

Locations

US (1)