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

This study has been completed.

Sponsor:

Information provided by:

Fibrocell Technologies, Inc.

ClinicalTrials.gov Identifier:

NCT00655889

First received: April 4, 2008

Last updated: June 3, 2009

Last verified: June 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	April 4, 2008
Last Updated Date	June 3, 2009
Start Date ^ICMJE	January 2006
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 4, 2008)	Investigator and subject evaluation of change from baseline [ Time Frame: Six months after first treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00655889 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency
Official Title ^ICMJE	Not Provided
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)
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Interdental Papillary Insufficiency
Intervention ^ICMJE	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)
Study Arm (s)	Experimental: Active Intervention: Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	13
Completion Date	July 2008
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00655889
Other Study ID Numbers ^ICMJE	IT-G-003
Has Data Monitoring Committee	No
Responsible Party	Dr. Sandra Calman/Chief Medical Officer & VP of Clinical Development, Isolagen Technologies, Inc.
Study Sponsor ^ICMJE	Fibrocell Technologies, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Fibrocell Technologies, Inc.
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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