Child's Adipose Cells: Capacity of Tissue Regeneration
Condition: Burns
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): adipose tissue sample
Intervention type(s): Procedure
Intervention description(s): adipose tissue sample
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cell therapy; Stromal Cells; Stem cells; Adipose tissue; Children