Dental Stem Cells and Bone Tissue Engineering (CELSORDINO)

Tooth, Impacted Clinical Trial

— CELSORDINO  

Official title:

Dental Stem Cells and Bone Tissue Engineering

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03194451
• Other study ID #: 2017-A00860-53/EUDRACT
• Status: Not yet recruiting
• Phase: N/A
• First received: June 16, 2017
• Last updated: June 22, 2017
• Start date: July 10, 2017
• Est. completion date: July 10, 2019

Study information

• Verified date: June 2017
• Source: Central Hospital, Nancy, France
• Contact: Vanessa MOBY, DD, PhD
• Phone: 0383154256
• Email: vanessa.moby[@]univ-lorraine.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main limitation in bone regeneration is the lack of vascularization of the newly shaped tissue. The main objective of this project is to check if the simultaneous differentiation of dental mesenchymal stem cells toward osteoblastic and endothelial lineage permits to obtain a new pre-vascularized tissue engineered bone construct.

We will then evaluate the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.

Description:

This project aims to develop a new pre-vascularized tissue engineered bone construct, using human cells of a simple and non invasive tissue source: dental pulp.

We will isolate mesenchymal stem cells from dental tissue of wisdom teeth, extracted from patients aged between 13 and 17 years old.

The objectives are: (i) to assess in combination the endothelial differentiation and osteoblastic differentiation of dental pulp stem cells (immature third molar); (ii) to study the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.

The differentiation will be monitored by evaluation of biosynthesized matrix, bone mineralization (immunohistochimie, Westen Blot), histological response (Von Kossa, Alizarin Red) and presence and quantification of pseudo-vascular structures (angiogenesis assay), compared to reference value (commercial differentiation medium).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 10, 2019
• Est. primary completion date: August 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• patients aged between 13 and 17 years, who will come to Dental Service of University Regional Hospital Center of Nancy in order to have a tooth avulsion.

• patient who has received a complete information about research organization and who is not opposed to the use of his own data.

• patient who the representatives of parental authority have received a complete information about research organization and who are not opposed to the use of children's data.

Exclusion Criteria:

• patients with local or general pathology

Related Conditions & MeSH terms

• Tooth, Impacted

Intervention

Other:
• non-interventional study
teeth collection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineralization	Measured parameter is equal or superior to reference value (commercial differentiation medium)	Day 28 of cell culture
Secondary	presence and quantification of pseudo-vascular structures	Measured parameter is equal or superior to reference value (commercial differentiation medium)	Day 28 of cell culture