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

Cleft Palate Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900014
• Other study ID #: 2015-12
• Secondary ID: 2015-A00984-45
• Status: Completed
• Phase: N/A
• Start date: September 18, 2015
• Est. completion date: August 4, 2023

Study information

• Verified date: August 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 4, 2023
• Est. primary completion date: September 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Procedure:
• sampling mesenchymal stem cells
nasal mesenchymental stem cells are collected in patients with cleft undergoing general anesthesia, during the initial surgical management of cleft

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of nasal mesenchymental stem cells		12 months