Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
NCT ID: NCT01858753
Last Updated: 2021-10-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2013-05-31
2016-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Autologous fibroblasts
Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.
Autologous fibroblasts
Sterile saline
Sterile saline will be injected into the scar to be evaluated.
Autologous fibroblasts
placebo sterile saline
Interventions
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Autologous fibroblasts
placebo sterile saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. Subject's burn scar to be treated is \<100 sq cm in size
4. Injury occurred ≤ 36 months prior to screening
5. By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint
6. Subject agrees to maintain any current physical therapy regimen for the duration of the study
7. Subject must be able to provide written informed consent and comply with the study requirements
8. 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
9. Subject has healthy, non-scarred post auricular skin area suitable for biopsy
10. Subject must have a normal complete blood count (CBC) and chemistry panel within 90 days prior to enrollment
Exclusion Criteria
2. Subjects for whom a post auricular biopsy cannot be collected for azficel-T production
3. Sunburn or sun damage in the area that will be used for biopsy
4. Plans to initiate any other new scar therapy during the study period
5. 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
6. History of active autoimmune disease or organ transplantation
7. Diagnosis of cancer, including basal cell carcinoma, unless successfully treated or in remission for a minimum of 6 months
8. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, Ehlers Danlos syndrome, etc.
9. Active systemic infection
10. Requires chronic antibiotic or steroidal therapy
11. Any conditions that are considered by the Investigator to be contraindications to biopsy or injection
12. Pregnant or lactating women, or women trying to become pregnant during the study
13. 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
14. 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
18 Years
ALL
No
Sponsors
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Castle Creek Biosciences, LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel D Lozano, MD
Role: PRINCIPAL_INVESTIGATOR
Lehigh Valley Health Network
Locations
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Univ of California David Medical Center
Sacramento, California, United States
Univ of California San Diego
San Diego, California, United States
Division of Burns and Trauma, Jackson Memorial Hospital
Miami, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
Richard M. Fairbanks Burn Center
Indianapolis, Indiana, United States
Long Island Plastic Surgical Group
Garden City, New York, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, United States
Univ of Washington, Harborview Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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FI-B-003
Identifier Type: -
Identifier Source: org_study_id