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

NCT01858753 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-10-13

Study results available
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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

BIOLOGICAL

Autologous fibroblasts

BIOLOGICAL

placebo sterile saline

Sponsors & Collaborators

  • Castle Creek Biosciences, LLC.

    lead INDUSTRY

Principal Investigators

  • Daniel D Lozano, MD · Lehigh Valley Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-05-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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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 NCT01858753 on ClinicalTrials.gov