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

This study has been completed.

First Received: April 4, 2008 Last Updated: June 3, 2009 History of Changes

Sponsored by:	Isolagen Technologies, Inc.
Information provided by:	Isolagen Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00655889

Purpose

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)

Condition	Intervention	Phase
Interdental Papillary Insufficiency	Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment

Further study details as provided by Isolagen Technologies, Inc.:

Primary Outcome Measures:

Investigator and subject evaluation of change from baseline [ Time Frame: Six months after first treatment ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	January 2006
Study Completion Date:	July 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental	Biological: Autologous Human Fibroblasts (Isolagen TherapyTM) Collection of biopsy from palate Papillary priming procedure Seven injection treatments to target sites Performance of study assessments (investigator and subject)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must be 18-70 years of age
Subject was treated in IT-G-002
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655889

Locations

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

Sponsors and Collaborators

Isolagen Technologies, Inc.

More Information

No publications provided

Responsible Party:	Isolagen Technologies, Inc. ( Dr. Sandra Calman/Chief Medical Officer & VP of Clinical Development )
Study ID Numbers:	IT-G-003
Study First Received:	April 4, 2008
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00655889 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 09, 2009