At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
Autologous Human Fibroblasts (azficel-T)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency
In Brief
A Phase 2 clinical trial evaluating Autologous Human Fibroblasts (azficel-T) for Interdental Papillary Insufficiency. Completed, enrolled 13 participants across 1 site.
Detailed 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, no NCT identification number)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInterdental Papillary Insufficiency
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
Primary CompletionApr 2008
First PostedApr 2008
Study CompletionJul 2008
TodayJul 2026
First PostedApr 10, 2008
Enrollment StartJan 1, 2006
Primary CompletionApr 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.2 years ago
Interventions
Autologous Human Fibroblasts (azficel-T)biological
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)