NCT01858753

Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Castle Creek Biosciences, LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to determine whether injection of autologous fibroblasts can increase the mobility (decrease the restriction) of burn scars. The study will assess the effects of azficel-T (autologous fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either: 1. An axillary scar causing 20-60% restriction of shoulder adduction 2. An anterior elbow scar causing 20-60% restriction of elbow extension 3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7 days) apart (depending on cell availability) and will be followed for efficacy (including range of motion measurements, scar pain and ability to perform activities) to Visit 7 and for safety to Visit 9 at 1 year.

Conditions

• Restrictive Burn Scars

Interventions

Type	Name	Description
BIOLOGICAL	Autologous fibroblasts
BIOLOGICAL	placebo sterile saline

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-05-01
• Completion: 2016-07-01
• First posted: 2013-05-21
• Last updated: 2021-10-13
• Results posted: 2021-07-19

Locations

9 sites across 1 country: United States