Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars
NCT00620737 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2012-02-10
Summary
The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to stable restrictive burn scars of an affected joint area.
Conditions
- Restrictive Burn Scars of Joint Area
Interventions
- BIOLOGICAL
-
Autologous Human Fibroblasts (Isolagen TherapyTM)
1. Collection of skin biopsy. 2. Administration of 2 study injections 3. Performance of various study assessments during clinic visits
- BIOLOGICAL
-
1. Collection of skin biopsy. 2. Administration of 2 study injections 3. Performance of various study assessments during clinic visits
Sponsors & Collaborators
-
Castle Creek Biosciences, LLC.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2008-12-31
Countries
- United States
Study Locations
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