Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
Public ClinicalTrials.gov record NCT01858753. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01858753
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 5 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2013
- Primary completion
- Apr 30, 2016
- Completion
- Jun 30, 2016
- Last update posted
- Oct 12, 2021
2013 – 2016
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of California David Medical Center | Sacramento | California | 95817 | — |
| Univ of California San Diego | San Diego | California | 92103 | — |
| Division of Burns and Trauma, Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Richard M. Fairbanks Burn Center | Indianapolis | Indiana | 46202 | — |
| Long Island Plastic Surgical Group | Garden City | New York | 11530 | — |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | — |
| Center for Innovation in Restorative Medicine | Pittsburgh | Pennsylvania | 15213 | — |
| Univ of Washington, Harborview Medical Center | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01858753, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 12, 2021 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01858753 live on ClinicalTrials.gov.