Child's Adipose Cells: Capacity of Tissue Regeneration (cicASChild)
Evaluation of Tissue Regeneration Potential (in the Skin) of Child's Adipose Cells During the Development.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Through this study, the medium term objective is to approach a clinical protocol for treatment of pathological scars in developing an appropriate way to deliver ADSC for a future clinical application, while ensuring the safety of such procedure.
The primary goal of this work is to determine whether ADSC from children prepared according to Good Manufacturing Practice (GMP), is associated with an improvement of wound healing in vivo as demonstrated with adult ADSC. To answer this question, 40 samples of adipose tissue of children obtained from settled surgery (inguinal hernia and vesico-ureteral reflux by suprapubic way) will be performed within the 2 groups of children; 0 to 1 year and 2 to 13 years, defined from data acquired in the previous protocol. Wound healing will be evaluated in a nude mouse model of skin burn. A macroscopic analysis will be carried out with two indexes described in the literature (re-epithelialization and scar contraction) and expressed as a percentage of the initial lesion at different times (3 days, 7 days, 10 days, 14 days, 21 days, 30 days). A microscopic analysis will be conducted to determine the rate of re-epithelialization (day 7) and the evolution of the skin structural parameters (dermal and epidermal thickness, density of collagen, inflammatory infiltration). These indexes will be defined in the treated group (burned mice and injected with pediatric ADSC) from control mice (burned but not injected with cells). A comparative analysis between the two groups of age will be conducted that will be also compared to data collected with adult ADSC.
To answer to the second part of this primary goal regarding to safety, the study will perform a long-term follow-up (1 yr) of burned mice injected with of ADSC, to obtain data in the animal after transplantation of cells and for further clinical study.
Complementary in vitro investigations still seems necessary to better understand the specificities of ADSC from pediatric origin and particularly to perform transcriptomic and epigenetic studies.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Toulouse, Francia, 31059
- CHU de Toulouse-Purpan
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
INCLUSION CRITERIA:
- absence of tumor pathology, known systemic or chronic viral
- absence of long-term treatment
signing informed consent form of persons exercising parental authority
1st group (20 children):
- Between 0 and less than or equal to 1 year
- Weighing at least 1500 g at birth
Age ≥ 37 weeks of amenorrhea
2nd group (20 children)
- Older than 1 year to 10 years
EXCLUSION CRITERIA:
- Children whose age is above 10 years
- premature babies with birth weight under 1500 grams
- Any child with a tumor pathology, a systemic disease, or whose serology (viral) would be known as positive (HIV 1 and 2, hepatitis B, C, ...).
- Any child following a long term treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: 0-1 year old child
Adipose tissue sample in 0-1 year old child with an act of surgery settled by cure of inguinal hernia, or by vesico-ureteral ebb by abdominal way
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adipose tissue sample
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Otro: >1-10 year old child
Adipose tissue sample in >1-10 year old child with an act of surgery settled by cure of inguinal hernia, or by vesico-ureteral ebb by abdominal way
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adipose tissue sample
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Efficacity of treatment as assessed by surface healed skin (cm2) in animal model
Periodo de tiempo: 1 month after injection
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Efficacy of ADSC in animal model healing
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1 month after injection
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Efficacity of treatment as assessed by surface healed skin (cm2) in animal model
Periodo de tiempo: 1 year after injection
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Efficacy of ADSC in animal model healing
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1 year after injection
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Security as assessed by absence of tumorigenicity at injection site in animal model
Periodo de tiempo: 1 month after injection
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Clinical security of treatment
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1 month after injection
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Security as assessed by absence of tumorigenicity at injection site in animal model
Periodo de tiempo: 1 year after injection
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Clinical security of treatment
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1 year after injection
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Philippe GALINIER, MD, PhD, Chirurgie pédiatrique - Hôpital des enfants
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 11 228 02
- 2011-A01469-32 (Identificador de registro: Agence National du Médicament et des Produits de santé)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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Ensayos clínicos sobre adipose tissue sample
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Hillel Yaffe Medical CenterDesconocido