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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
  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 2

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

Further study details as provided by Fibrocell 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
Experimental: Active Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)
  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)

  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
Fibrocell Technologies, Inc.
  More Information

No publications provided

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

ClinicalTrials.gov processed this record on May 21, 2013