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NCT01858753 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
A Phase 2 study, sponsored by Castle Creek Biosciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01858753: Clinical Trial Phase 2 study, sponsored by Castle Creek Biosciences.
NCT01858753 is a Phase 2 study that was terminated before completion, run by Castle Creek Biosciences. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01858753, a Phase 2 study, was terminated before completion, sponsored by Castle Creek Biosciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Interventions
- BIOLOGICAL Autologous fibroblasts
- BIOLOGICAL placebo sterile saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
Why NCT01858753 stopped before completion
NCT01858753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Autologous fibroblasts is the first listed.
NCT01858753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01858753 about?
NCT01858753 is a clinical study titled "Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars". 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 hav...
What is the current status of trial NCT01858753?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2013-05. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01858753?
The interventions under investigation include: Autologous fibroblasts (BIOLOGICAL), placebo sterile saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT01858753?
This trial is sponsored by Castle Creek Biosciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01858753's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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