Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
Primary Purpose
Restrictive Burn Scars
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous fibroblasts
placebo sterile saline
Sponsored by
About this trial
This is an interventional treatment trial for Restrictive Burn Scars focused on measuring burn scars, restrictive, contractures, autologous fibroblasts
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Univ of California David Medical Center
- Univ of California San Diego
- Division of Burns and Trauma, Jackson Memorial Hospital
- Loyola University Medical Center
- Richard M. Fairbanks Burn Center
- Long Island Plastic Surgical Group
- Lehigh Valley Health Network
- Center for Innovation in Restorative Medicine
- Univ of Washington, Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Autologous fibroblasts
Sterile saline
Arm Description
Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.
Sterile saline will be injected into the scar to be evaluated.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01858753
First Posted
May 10, 2013
Last Updated
September 17, 2021
Sponsor
Castle Creek Biosciences, LLC.
1. Study Identification
Unique Protocol Identification Number
NCT01858753
Brief Title
Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
Official Title
A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
unable to enroll
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Castle Creek Biosciences, LLC.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restrictive Burn Scars
Keywords
burn scars, restrictive, contractures, autologous fibroblasts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous fibroblasts
Arm Type
Experimental
Arm Description
Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.
Arm Title
Sterile saline
Arm Type
Placebo Comparator
Arm Description
Sterile saline will be injected into the scar to be evaluated.
Intervention Type
Biological
Intervention Name(s)
Autologous fibroblasts
Other Intervention Name(s)
Azficel-T
Intervention Type
Biological
Intervention Name(s)
placebo sterile saline
Primary Outcome Measure Information:
Title
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
Description
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.
Time Frame
Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
Title
Percentage CFB of ROM of the Affected Joint
Description
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.
Time Frame
Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
Title
Percentage CFB of ROM of the Affected Joint
Description
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.
Time Frame
Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
Title
Percentage CFB of ROM of the Affected Joint
Description
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.
Time Frame
Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
Title
Percentage CFB of ROM of the Affected Joint
Description
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.
Time Frame
Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel D Lozano, MD
Organizational Affiliation
Lehigh Valley Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ of California David Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Univ of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Division of Burns and Trauma, Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Richard M. Fairbanks Burn Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Long Island Plastic Surgical Group
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Center for Innovation in Restorative Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Univ of Washington, Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
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