Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that was terminated before completion, run by Castle Creek Biosciences. The registered enrollment target is 5 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01858753
The ClinicalTrials.gov registry entry for NCT01858753 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Castle Creek Biosciences, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Autologous fibroblasts is the first listed.
NCT01858753 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.