Dental Stem Cells and Bone Tissue Engineering (CELSORDINO) (CELSORDINO)

Dental Stem Cells and Bone Tissue Engineering

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.

Study Overview

• Status: Unknown
• Conditions: Tooth, Impacted
• Intervention / Treatment: Other: non-interventional study

Detailed 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).

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 13 and 17 years, who will be operated for wisdom tooth avulsion

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineralization	Measured parameter is equal or superior to reference value (commercial differentiation medium)	Day 28 of cell culture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence and quantification of pseudo-vascular structures	Measured parameter is equal or superior to reference value (commercial differentiation medium)	Day 28 of cell culture

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Vanessa MOBY, DD, PhD, IMoPA, UMR-CNRS 7365 CNRS-UL, Medicine Faculty

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 10, 2017
• Primary Completion (ANTICIPATED): August 20, 2017
• Study Completion (ANTICIPATED): July 10, 2019

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (ACTUAL): June 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: bone tissue engineering, dental stem cell differentiation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: 2017-A00860-53/EUDRACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No