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

NCT00655889 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-03-23

Study results available
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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)

Conditions

  • Interdental Papillary Insufficiency

Interventions

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)

Sponsors & Collaborators

  • Castle Creek Biosciences, LLC.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-04-30
Completion
2008-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00655889 on ClinicalTrials.gov