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.
研究概览
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Toulouse、法国、31059
- CHU de Toulouse-Purpan
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
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
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.