Validation of a Production Method of Stem Cell Isolated From the Nasal Cavity for an Innovative Cell Therapy of Cleft Palate

Not Applicable

Completed

• Conditions: Cleft Palate
• Interventions: Procedure: sampling mesenchymal stem cells

• Registration Number: NCT02900014
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-18
• Primary Completion: 2015-09-22
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-14
• Status Verified: 2023-08
• Study Completion: 2023-08-04
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with cleft	sampling mesenchymal stem cells	-

Primary Outcome Measures

Name	Time	Method
number of nasal mesenchymental stem cells	12 months

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France