Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases

Conditions
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Facial Wrinkles and Creases

Intervention / Treatment
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* Biological: Autologous Human Fibroblasts (azficel-T)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, at least 18 years of age High Investigator wrinkle severity assessment score Subject assessment of dissatisfaction of facial appearance Provide written informed consent and comply with the study requirements Negative pregnancy test at screening visit Healthy, non-scarred skin for biopsy Exclusion Criteria: Low Investigator wrinkle severity assessment score Subject assessment of satisfaction of facial appearance Physical attributes which prevent the assessment or treatment of the facial wrinkles Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical trial Previous treatment with Isolagen Therapy History of active autoimmune disease or organ transplantation Diagnosis of cancer, receiving active treatment History of pigmentary disorders which can affect the face Active or chronic skin disease Known genetic disorders affecting fibroblasts or collagen Active systemic infection Requires chronic antibiotic or steroidal therapy Use of certain cosmetic treatments & procedures Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects Pregnant or lactating women or women trying to become pregnant Known allergic reaction to components of study treatment and/or study injection procedure Excessive exposure to sun or sunburn in the post-auricular area Subject has any disorder that may prevent compliance Subject who is part of the study staff, a family member or friend

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Biological: Autologous Human Fibroblasts (azficel-T)<br>* Collection of 3 mm biopsies Two injection treatments of facial wrinkles and creases Conduct of study assessments<br>* Other names: LAVIV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best. | Baseline (prior to first treatment) compared to 6 months post last treatment | 
| Independent Panel Global Improvement Assessment Compared to Baseline | An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best. | Baseline (prior to treatment) compared to 6 months post last treatment |