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

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.

Timeline

Start

2013-05

Primary completion

2016-05

Completion

2016-07

Outcome

Outcome not reported

Stopped (Enrollment): “unable to enroll”

Drugs

Indications

No indication recorded.