NCT02779205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

July 10, 2015

Last Update Submit

May 10, 2017

Conditions

Burns

Keywords

Cell therapyStromal CellsStem cellsAdipose tissueChildren

Outcome Measures

Primary Outcomes (4)

  • Efficacity of treatment as assessed by surface healed skin (cm2) in animal model

    Efficacy of ADSC in animal model healing

    1 month after injection

  • Efficacity of treatment as assessed by surface healed skin (cm2) in animal model

    Efficacy of ADSC in animal model healing

    1 year after injection

  • Security as assessed by absence of tumorigenicity at injection site in animal model

    Clinical security of treatment

    1 month after injection

  • Security as assessed by absence of tumorigenicity at injection site in animal model

    Clinical security of treatment

    1 year after injection

Study Arms (2)

0-1 year old child

OTHER

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

>1-10 year old child

OTHER

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

Interventions

adipose tissue samplePROCEDURE

adipose tissue sample

0-1 year old child>1-10 year old child

Eligibility Criteria

Age37 Weeks - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • absence of tumor pathology, known systemic or chronic viral
  • absence of long-term treatment
  • signing informed consent form of persons exercising parental authority
  • st 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
  • nd group (20 children)
  • Older than 1 year to 10 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse-Purpan

Toulouse, 31059, France

Location

Related Publications (1)

  • Abbo O, Taurand M, Monsarrat P, Raymond I, Arnaud E, De Barros S, Auriol F, Galinier P, Casteilla L, Planat-Benard V. Comparison between pediatric and adult adipose mesenchymal stromal cells. Cytotherapy. 2017 Mar;19(3):395-407. doi: 10.1016/j.jcyt.2016.11.012. Epub 2016 Dec 28.

    PMID: 28040462RESULT

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Philippe GALINIER, MD, PhD

    Chirurgie pédiatrique - Hôpital des enfants

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2015

First Posted

May 20, 2016

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)