Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
17 de setembro de 2021 atualizado por: 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
5
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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Sacramento, California, Estados Unidos, 95817
- Univ of California David Medical Center
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San Diego, California, Estados Unidos, 92103
- Univ of California San Diego
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Florida
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Miami, Florida, Estados Unidos, 33136
- Division of Burns and Trauma, Jackson Memorial Hospital
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Illinois
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Richard M. Fairbanks Burn Center
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New York
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Garden City, New York, Estados Unidos, 11530
- Long Island Plastic Surgical Group
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos, 18103
- Lehigh Valley Health Network
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Center for Innovation in Restorative Medicine
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Univ of Washington, Harborview Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Outros nomes:
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Comparador de Placebo: Sterile saline
Sterile saline will be injected into the scar to be evaluated.
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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Daniel D Lozano, MD, Lehigh Valley Health Network
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2013
Conclusão Primária (Real)
1 de maio de 2016
Conclusão do estudo (Real)
1 de julho de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
10 de maio de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de maio de 2013
Primeira postagem (Estimativa)
21 de maio de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de outubro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de setembro de 2021
Última verificação
1 de setembro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FI-B-003
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