Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles

Summary

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.

Timeline

Start

2006-11

Primary completion

2008-07

Completion

2009-05

Outcome

Met primary endpoint

registry NUMBER Autologous Fibroblasts: 50 participants NUMBER Placebo: 19 participants analysis (superiority or other test); Autologous Fibroblasts vs Placebo; p <.00001 NCT00655356 ↗

registry NUMBER Autologous Fibroblasts: 21 participants NUMBER Placebo: 8 participants analysis (superiority or other test); Autologous Fibroblasts vs Placebo; p = .0075 NCT00655356 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	azficel-T	Cell therapy	—	Other

Indications

No indication recorded.