Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
17 september 2021 bijgewerkt door: Castle Creek Biosciences, LLC.
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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
5
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Sacramento, California, Verenigde Staten, 95817
- Univ of California David Medical Center
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San Diego, California, Verenigde Staten, 92103
- Univ of California San Diego
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Florida
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Miami, Florida, Verenigde Staten, 33136
- Division of Burns and Trauma, Jackson Memorial Hospital
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Illinois
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Maywood, Illinois, Verenigde Staten, 60153
- Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202
- Richard M. Fairbanks Burn Center
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New York
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Garden City, New York, Verenigde Staten, 11530
- Long Island Plastic Surgical Group
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Pennsylvania
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Allentown, Pennsylvania, Verenigde Staten, 18103
- Lehigh Valley Health Network
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- Center for Innovation in Restorative Medicine
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Washington
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Seattle, Washington, Verenigde Staten, 98104
- Univ of Washington, Harborview Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Autologous fibroblasts
Autologous fibroblasts grown in culture from skin biopsy taken from patient.
The cells will be injected into the scars to be treated.
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Andere namen:
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Placebo-vergelijker: Sterile saline
Sterile saline will be injected into the scar to be evaluated.
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Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
Tijdsspanne: Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
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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.
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Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
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Percentage CFB of ROM of the Affected Joint
Tijdsspanne: Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
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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.
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Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
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Percentage CFB of ROM of the Affected Joint
Tijdsspanne: Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
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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.
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Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
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Percentage CFB of ROM of the Affected Joint
Tijdsspanne: Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
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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.
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Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
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Percentage CFB of ROM of the Affected Joint
Tijdsspanne: Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)
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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.
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Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Daniel D Lozano, MD, Lehigh Valley Health Network
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2013
Primaire voltooiing (Werkelijk)
1 mei 2016
Studie voltooiing (Werkelijk)
1 juli 2016
Studieregistratiedata
Eerst ingediend
10 mei 2013
Eerst ingediend dat voldeed aan de QC-criteria
20 mei 2013
Eerst geplaatst (Schatting)
21 mei 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 oktober 2021
Laatste update ingediend die voldeed aan QC-criteria
17 september 2021
Laatst geverifieerd
1 september 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FI-B-003
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