ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00655889
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : August 15, 2013
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.

April 4, 2008
April 10, 2008
June 4, 2013
August 15, 2013
August 15, 2013
January 2006
April 2008   (Final data collection date for primary outcome measure)
  • Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) [ Time Frame: Baseline (prior to first study treatment) compared to six months after first treatment ]
    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.
  • Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) [ Time Frame: Baseline (prior to first study treatment) compared to six months after first treatment ]
    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.
Investigator and subject evaluation of change from baseline [ Time Frame: Six months after first treatment ]
Complete list of historical versions of study NCT00655889 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency
Not Provided
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)
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Interdental Papillary Insufficiency
Biological: Autologous Human Fibroblasts (azficel-T)
  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)
Other Name: LAVIV
Experimental: Active
Intervention: Biological: Autologous Human Fibroblasts (azficel-T)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
Same as current
July 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00655889
IT-G-003
No
Not Provided
Not Provided
Fibrocell Technologies, Inc.
Fibrocell Technologies, Inc.
Not Provided
Not Provided
Fibrocell Technologies, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP