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

Phase 2

Terminated

Interventions: Biological: Autologous fibroblasts
Biological: placebo sterile saline

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:

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.

Recruitment & Eligibility

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:
1. An axillary scar causing 20-60% restriction of shoulder abduction
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
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

Arm && Interventions

Group	Intervention	Description
Sterile saline	Autologous fibroblasts	Sterile saline will be injected into the scar to be evaluated.
Autologous fibroblasts	Autologous fibroblasts	Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.
Sterile saline	placebo sterile saline	Sterile saline will be injected into the scar to be evaluated.

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint	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	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.

Secondary Outcome Measures

Name	Time	Method

Locations (9): Richard M. Fairbanks Burn Center
🇺🇸
Indianapolis, Indiana, United States
Center for Innovation in Restorative Medicine
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Pittsburgh, Pennsylvania, United States
Division of Burns and Trauma, Jackson Memorial Hospital
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Miami, Florida, United States
Lehigh Valley Health Network
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Allentown, Pennsylvania, United States
Univ of Washington, Harborview Medical Center
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Seattle, Washington, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Univ of California David Medical Center
🇺🇸
Sacramento, California, United States
Univ of California San Diego
🇺🇸
San Diego, California, United States
Long Island Plastic Surgical Group
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Garden City, New York, United States