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NCT00620737 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL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

No results posted yet for this study

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

Placebo

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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Entities

Drugs

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 NCT00620737 on ClinicalTrials.gov