Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
17 września 2021 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
5
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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California
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Sacramento, California, Stany Zjednoczone, 95817
- Univ of California David Medical Center
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San Diego, California, Stany Zjednoczone, 92103
- Univ of California San Diego
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Florida
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Miami, Florida, Stany Zjednoczone, 33136
- Division of Burns and Trauma, Jackson Memorial Hospital
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Illinois
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Maywood, Illinois, Stany Zjednoczone, 60153
- Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- Richard M. Fairbanks Burn Center
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New York
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Garden City, New York, Stany Zjednoczone, 11530
- Long Island Plastic Surgical Group
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Pennsylvania
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Allentown, Pennsylvania, Stany Zjednoczone, 18103
- Lehigh Valley Health Network
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- Center for Innovation in Restorative Medicine
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Washington
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Seattle, Washington, Stany Zjednoczone, 98104
- Univ of Washington, Harborview Medical Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Inne nazwy:
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Komparator placebo: Sterile saline
Sterile saline will be injected into the scar to be evaluated.
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Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Daniel D Lozano, MD, Lehigh Valley Health Network
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 maja 2013
Zakończenie podstawowe (Rzeczywisty)
1 maja 2016
Ukończenie studiów (Rzeczywisty)
1 lipca 2016
Daty rejestracji na studia
Pierwszy przesłany
10 maja 2013
Pierwszy przesłany, który spełnia kryteria kontroli jakości
20 maja 2013
Pierwszy wysłany (Oszacować)
21 maja 2013
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
13 października 2021
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 września 2021
Ostatnia weryfikacja
1 września 2021
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FI-B-003
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