Restrictive Burn ScarsPhase 2NCT01858753

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

A Phase 2 study testing Autologous fibroblasts in people with Restrictive Burn Scars, run by Castle Creek Biosciences, LLC. at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Restrictive Burn Scars
What is being tested?: Autologous fibroblasts
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 9 sitesUnited States
Study dates: May 2013to Jul 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is at least 18 years of age
Subject has a unilateral burn scar of a jointed area (i.e., finger, elbow, shoulder) 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:
An axillary scar causing 20-60% restriction of shoulder abduction
An anterior elbow scar causing 20-60% restriction of elbow extension
A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension
Subject's burn scar to be treated is <100 sq cm in size

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Injury occurred ≤ 36 months prior to screening
By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint
Subject agrees to maintain any current physical therapy regimen for the duration of the study
Subject must be able to provide written informed consent and comply with the study requirements
Females of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to the first treatment, and must agree to use a reliable means of birth control for the duration of the study
Subject has healthy, non-scarred post auricular skin area suitable for biopsy
Subject must have a normal complete blood count (CBC) and chemistry panel within 90 days prior to enrollment

Who cannot join

Restrictive burn scars that are primarily classified as keloid scars
Subjects for whom a post auricular biopsy cannot be collected for azficel-T production
Sunburn or sun damage in the area that will be used for biopsy
Plans to initiate any other new scar therapy during the study period
Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study
History of active autoimmune disease or organ transplantation

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Diagnosis of cancer, including basal cell carcinoma, unless successfully treated or in remission for a minimum of 6 months
Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, Ehlers Danlos syndrome, etc.
Active systemic infection
Requires chronic antibiotic or steroidal therapy
Any conditions that are considered by the Investigator to be contraindications to biopsy or injection
Pregnant or lactating women, or women trying to become pregnant during the study
Subject has any disorder that may prevent compliance, such as history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the Investigator's opinion, interfere with the study
Presence of other disease or condition that would result in impairment of the range of motion of the extremity, e.g., rheumatoid arthritis or stroke

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Long Island Plastic Surgical Group
Garden City, New York, 11530
Richard M. Fairbanks Burn Center
Indianapolis, Indiana, 46202
Loyola University Medical Center
Maywood, Illinois, 60153
Division of Burns and Trauma, Jackson Memorial Hospital
Miami, Florida, 33136
Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, 15213
Univ of California David Medical Center
Sacramento, California, 95817
Univ of California San Diego
San Diego, California, 92103
Univ of Washington, Harborview Medical Center
Seattle, Washington, 98104

Other trials in United States

About this study

Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled 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 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:

An axillary scar causing 20-60% restriction of shoulder adduction
An anterior elbow scar causing 20-60% restriction of elbow extension
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
Being tested: Autologous fibroblasts, placebo sterile saline
Keywords: burn scars, restrictive, contractures, autologous fibroblasts
Medical subject headings: Contracture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous fibroblastsBiological
Also called Azficel-T
placebo sterile salineBiological

Study groups in NCT01858753
Study group	Role	What they receive
Autologous fibroblasts	Experimental	Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated. Receives: Biological: Autologous fibroblasts
Sterile saline	Placebo comparator	Sterile saline will be injected into the scar to be evaluated. Receives: Biological: Autologous fibroblasts; Biological: placebo sterile saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
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.
Measured: Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
Percentage CFB of ROM of the Affected Joint
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.
Measured: Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
Percentage CFB of ROM of the Affected Joint
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.
Measured: Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
Percentage CFB of ROM of the Affected Joint
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.
Measured: Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
Percentage CFB of ROM of the Affected Joint
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.
Measured: Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Jul 2016

First posted21 May 2013 (estimated)
Study startMay 2013
Primary completionMay 2016
Study completionJul 2016

Why it stopped: unable to enroll

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Restrictive Burn ScarsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01858753
Sponsor's protocol ID: FI-B-003
Status last verified: Sep 2021
First submitted: 10 May 2013
Last updated: 13 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
ClinicalTrials.gov ID: NCT01858753
Acronym / sponsor ID: FI-B-003
Conditions: Restrictive Burn Scars
Keywords: burn scars, restrictive, contractures, autologous fibroblasts
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: unable to enroll
Enrolment: 5 participants (actual)
Lead sponsor: Castle Creek Biosciences, LLC.Industry (pharma, biotech, devices)
Study start: May 2013
Primary completion: May 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 21 May 2013 (estimated)
Results: Posted 19 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An axillary scar causing 20-60% restriction of shoulder adduction
An anterior elbow scar causing 20-60% restriction of elbow extension
A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Autologous fibroblasts	Experimental	Biological: Autologous fibroblastsAutologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.
Sterile saline	Placebo comparator	Biological: Autologous fibroblasts, Biological: placebo sterile salineSterile saline will be injected into the scar to be evaluated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Subject is at least 18 years of age
Subject has a unilateral burn scar of a jointed area (i.e., finger, elbow, shoulder) 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:
Subject's burn scar to be treated is <100 sq cm in size
Injury occurred ≤ 36 months prior to screening
By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint

Key exclusion criteria (14 listed)

Restrictive burn scars that are primarily classified as keloid scars
Subjects for whom a post auricular biopsy cannot be collected for azficel-T production
Sunburn or sun damage in the area that will be used for biopsy
Plans to initiate any other new scar therapy during the study period
Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autologous fibroblastsAlso: Azficel-T	Biological	Autologous fibroblasts, Sterile saline
placebo sterile saline	Biological	Sterile saline

Primary outcome

Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
Time frame: Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
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.
Percentage CFB of ROM of the Affected Joint
Time frame: Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
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.
Percentage CFB of ROM of the Affected Joint
Time frame: Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
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.
Percentage CFB of ROM of the Affected Joint
Time frame: Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
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.
Percentage CFB of ROM of the Affected Joint
Time frame: Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)
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.

Results and safety

Results posted to the registry on 19 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Autologous Fibroblasts	5	0
Sterile Saline	0	0

Primary outcome: Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint

Time frame: Baseline and post-treatment (visit occurred between 194 - 208 days from baseline). Mean (Standard Deviation). Unit: percent change

Measure	Autologous Fibroblasts n = 3	Sterile Saline n = 0
Value	52.0 (23.40)	–

Population analysed: Modified intent to treat population (mITT)

Primary outcome: Percentage CFB of ROM of the Affected Joint

Time frame: Baseline and post-treatment (visit occurred between 23 - 37 days from baseline). Mean (Standard Deviation). Unit: percent change

Measure	Autologous Fibroblasts n = 3	Sterile Saline n = 0
Value	39.6 (10.88)	–

Population analysed: Modified intent to treat population

Primary outcome: Percentage CFB of ROM of the Affected Joint

Time frame: Baseline and post-treatment (visit occurred between 53 - 67 days from baseline). Mean (Standard Deviation). Unit: percent change

Measure	Autologous Fibroblasts n = 3	Sterile Saline n = 0
Value	54.9 (25.86)	–

Population analysed: Modified intent to treat population

Primary outcome: Percentage CFB of ROM of the Affected Joint

Time frame: Baseline and post-treatment (visit occurred between 93 - 97 days from baseline). Mean (Standard Deviation). Unit: percent change

Measure	Autologous Fibroblasts n = 3	Sterile Saline n = 0
Value	56.0 (29.33)	–

Population analysed: Modified intent to treat population

Adverse events

Time frame: Adverse events were collected from the time of the subject's biopsy through visit 9 (i.e., 360 days from their second treatment).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Autologous Fibroblasts	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Sterile Saline	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects enrolled and completed; some data uninterpretable due to late data entry. With low enrollment (three subjects in mITT population and five subjects in safety population), a meaningful statistical analysis was not possible for this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel D Lozano, MD principal investigator

Lehigh Valley Health Network

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous fibroblasts in people with Restrictive Burn Scars, run by Castle Creek Biosciences, LLC. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint (time frame: Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01858753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.