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.
Trial 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. Read more about this study
- 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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Castle Creek Biosciences, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel D Lozano, MD, Principal investigator, Lehigh Valley Health Network
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.
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.
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
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?
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.