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

June 22, 2017 updated by: Central Hospital, Nancy, France

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Vanessa MOBY, DD, PhD, IMoPA, UMR-CNRS 7365 CNRS-UL, Medicine Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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