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

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ClinicalTrials.gov Identifier: NCT02779205
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

Condition or disease Intervention/treatment Phase
Burns Procedure: adipose tissue sample Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Tissue Regeneration Potential (in the Skin) of Child's Adipose Cells During the Development.
Study Start Date : January 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
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
Procedure: adipose tissue sample
adipose tissue sample

>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
Procedure: adipose tissue sample
adipose tissue sample




Primary Outcome Measures :
  1. Efficacity of treatment as assessed by surface healed skin (cm2) in animal model [ Time Frame: 1 month after injection ]
    Efficacy of ADSC in animal model healing

  2. Efficacity of treatment as assessed by surface healed skin (cm2) in animal model [ Time Frame: 1 year after injection ]
    Efficacy of ADSC in animal model healing

  3. Security as assessed by absence of tumorigenicity at injection site in animal model [ Time Frame: 1 month after injection ]
    Clinical security of treatment

  4. Security as assessed by absence of tumorigenicity at injection site in animal model [ Time Frame: 1 year after injection ]
    Clinical security of treatment



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Ages Eligible for Study:   37 Weeks to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779205


Locations
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France
CHU de Toulouse-Purpan
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Philippe GALINIER, MD, PhD Chirurgie pédiatrique - Hôpital des enfants

Publications of Results:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02779205     History of Changes
Other Study ID Numbers: 11 228 02
2011-A01469-32 ( Registry Identifier: Agence National du Médicament et des Produits de santé )
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
Cell therapy
Stromal Cells
Stem cells
Adipose tissue
Children