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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Toulouse, Frankrike, 31059
- CHU de Toulouse-Purpan
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Övrig: 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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Övrig: >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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Efficacity of treatment as assessed by surface healed skin (cm2) in animal model
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1 year after injection
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Clinical security of treatment
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1 year after injection
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Philippe GALINIER, MD, PhD, Chirurgie pédiatrique - Hôpital des enfants
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 11 228 02
- 2011-A01469-32 (Registeridentifierare: Agence National du Médicament et des Produits de santé)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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