Cleft Palate
Conditions
Brief summary
Cell therapy appears to be an alternative to treat bone defects. Scientific advances have shown in animal models and in humans that mesenchymal stem cells were good candidates to support cellular bone regeneration after transplantation. However, their collection requires invasive sampling usually bone marrow. A new candidate stem cells able to stimulate bone regeneration has recently been identified in the nasal cavity, these cells are called ecto-mesenchymal cells. These stem cells have very similar biological characteristics of mesenchymal stem cells of bone marrow. They exhibit a high mitogenic activity and hold great potential for differentiation into osteoblast lineage. Given their properties and their ease of access within the nasal cavity, ecto-mesenchymal stem cells offer new prospects for cell therapy targeting bone involvement. In this context, the ecto-mesenchymal stem cells represent a nasal bone reconstruction interesting alternative in particular in indication of the cleft. They are directly and easily accessible in these children when conventional surgical reconstruction. The investigators propose in this study to validate a production method of stem cell called ecto-mesenchymal isolated from a biopsy of the nasal cavity of children with cleft lip and palate to be able to soon propose cell therapy innovative in this indication.
Interventions
PROCEDUREsampling mesenchymal stem cells
nasal mesenchymental stem cells are collected in patients with cleft undergoing general anesthesia, during the initial surgical management of cleft
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* Paediatric patients with unilateral cleft lip and alveolar (or maxilla) or labio-maxillo-palatal, requiring surgical management of reconstruction * Children weighing more than 2 kg
Exclusion criteria
* Children with concomitant pathology that might alter bone turnover: osteogenesis imperfecta, kidney failure, chronic inflammatory diseases, infections, other diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of nasal mesenchymental stem cells | 12 months |
Countries
France
Outcome results
None listed