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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00655889
First received: April 4, 2008
Last updated: June 4, 2013
Last verified: June 2013
  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 (azficel-T)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


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
Experimental: Active 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Fibrocell Technologies, Inc.
  More Information

No publications provided

Responsible Party: Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00655889     History of Changes
Other Study ID Numbers: IT-G-003
Study First Received: April 4, 2008
Results First Received: June 4, 2013
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 29, 2014