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Child's Adipose Cells: Capacity of Tissue Regeneration (cicASChild)

2017年5月10日 更新者:University Hospital, Toulouse

Evaluation of Tissue Regeneration Potential (in the Skin) of Child's Adipose Cells During the Development.

The beneficial effect related to the administration of adipose tissue-derived stromal cells (ADSC) is demonstrated in various situations of physiological and pathological wound healing, thus opening a new field for cell therapy. Despite the use of new technologies, management of burns in children as well as congenital malformation such as hypospadias and cleft lip and/ or cleft palate can lead to aesthetic and functional sequelae requiring multiple surgical procedures. Cell therapy based on the administration of the ADSC seems a promising issue in such indications, however, to date no study has been conducted with ADSC from a pediatric population. An initial study (Protocol 0808203) allowed investigors to obtain the first samples of adipose tissue from children and to conduct an in vitro comparative study on the characterization and properties of the ADSC from children compared to adults. In the continuity, this second study aims to complete knowledge on the efficacy and safety of children ADSC cell therapy assessed in an animal model of skin wound healing developed in the lab.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

38

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Toulouse、法国、31059
        • CHU de Toulouse-Purpan

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

8个月 至 10年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他: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
adipose tissue sample
其他:>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
adipose tissue sample

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Efficacity of treatment as assessed by surface healed skin (cm2) in animal model
大体时间:1 month after injection
Efficacy of ADSC in animal model healing
1 month after injection
Efficacity of treatment as assessed by surface healed skin (cm2) in animal model
大体时间:1 year after injection
Efficacy of ADSC in animal model healing
1 year after injection
Security as assessed by absence of tumorigenicity at injection site in animal model
大体时间:1 month after injection
Clinical security of treatment
1 month after injection
Security as assessed by absence of tumorigenicity at injection site in animal model
大体时间:1 year after injection
Clinical security of treatment
1 year after injection

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Philippe GALINIER, MD, PhD、Chirurgie pédiatrique - Hôpital des enfants

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (实际的)

2015年1月1日

研究完成 (实际的)

2015年1月1日

研究注册日期

首次提交

2015年7月10日

首先提交符合 QC 标准的

2016年5月17日

首次发布 (估计)

2016年5月20日

研究记录更新

最后更新发布 (实际的)

2017年5月12日

上次提交的符合 QC 标准的更新

2017年5月10日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 11 228 02
  • 2011-A01469-32 (注册表标识符:Agence National du Médicament et des Produits de santé)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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