Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
17 de septiembre de 2021 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
5
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
California
-
Sacramento, California, Estados Unidos, 95817
- Univ of California David Medical Center
-
San Diego, California, Estados Unidos, 92103
- Univ of California San Diego
-
-
Florida
-
Miami, Florida, Estados Unidos, 33136
- Division of Burns and Trauma, Jackson Memorial Hospital
-
-
Illinois
-
Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46202
- Richard M. Fairbanks Burn Center
-
-
New York
-
Garden City, New York, Estados Unidos, 11530
- Long Island Plastic Surgical Group
-
-
Pennsylvania
-
Allentown, Pennsylvania, Estados Unidos, 18103
- Lehigh Valley Health Network
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Center for Innovation in Restorative Medicine
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98104
- Univ of Washington, Harborview Medical Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
Otros nombres:
|
|
Comparador de placebos: Sterile saline
Sterile saline will be injected into the scar to be evaluated.
|
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
Periodo de tiempo: 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.
|
Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
|
|
Percentage CFB of ROM of the Affected Joint
Periodo de tiempo: Baseline and post-treatment (visit occurred between 23 - 37 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.
|
Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
|
|
Percentage CFB of ROM of the Affected Joint
Periodo de tiempo: Baseline and post-treatment (visit occurred between 53 - 67 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.
|
Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
|
|
Percentage CFB of ROM of the Affected Joint
Periodo de tiempo: Baseline and post-treatment (visit occurred between 93 - 97 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.
|
Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
|
|
Percentage CFB of ROM of the Affected Joint
Periodo de tiempo: 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.
|
Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Daniel D Lozano, MD, Lehigh Valley Health Network
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2013
Finalización primaria (Actual)
1 de mayo de 2016
Finalización del estudio (Actual)
1 de julio de 2016
Fechas de registro del estudio
Enviado por primera vez
10 de mayo de 2013
Primero enviado que cumplió con los criterios de control de calidad
20 de mayo de 2013
Publicado por primera vez (Estimar)
21 de mayo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
17 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FI-B-003
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .