- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02779205
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.
Panoramica dello studio
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Toulouse, Francia, 31059
- CHU de Toulouse-Purpan
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: 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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Altro: >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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Efficacity of treatment as assessed by surface healed skin (cm2) in animal model
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 year after injection
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Clinical security of treatment
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1 year after injection
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Philippe GALINIER, MD, PhD, Chirurgie pédiatrique - Hôpital des enfants
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 11 228 02
- 2011-A01469-32 (Identificatore di registro: Agence National du Médicament et des Produits de santé)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Brucia
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Hospices Civils de LyonCompletato
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Konya Meram State HospitalCompletatoBurns Grado SecondoTacchino
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Miloš PotkonjakGeneral Hospital of Novo mestoReclutamentoPediatrico | Burns Grado SecondoSlovenia
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Senem AndıNon ancora reclutamento
Prove cliniche su adipose tissue sample
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Hillel Yaffe Medical CenterSconosciuto