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NCT00655889 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency
A Phase 2 study, sponsored by Castle Creek Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00655889: Completed Phase 2 study, sponsored by Castle Creek Biosciences.
NCT00655889 is a Phase 2 study that has completed, run by Castle Creek Biosciences. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00655889, a Phase 2 study, has completed, sponsored by Castle Creek Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study 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)
Primary Outcome
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.
Interventions
- BIOLOGICAL Autologous Human Fibroblasts (azficel-T)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
What the finished NCT00655889 record still lists
NCT00655889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Autologous Human Fibroblasts (azficel-T) is the first listed.
NCT00655889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00655889 about?
NCT00655889 is a clinical study titled "Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency". 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)
What is the current status of trial NCT00655889?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2006-01. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00655889?
The interventions under investigation include: Autologous Human Fibroblasts (azficel-T) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00655889?
This trial is sponsored by Castle Creek Biosciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00655889's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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