ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03194451
Recruitment Status : Not yet recruiting
First Posted : June 21, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief 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.


Condition or disease Intervention/treatment
Tooth, Impacted 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
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dental Stem Cells and Bone Tissue Engineering
Estimated Study Start Date : July 10, 2017
Estimated Primary Completion Date : August 20, 2017
Estimated Study Completion Date : July 10, 2019

Intervention Details:
  • Other: non-interventional study
    teeth collection


Primary Outcome Measures :
  1. Bone mineralization [ Time Frame: Day 28 of cell culture ]
    Measured parameter is equal or superior to reference value (commercial differentiation medium)


Secondary Outcome Measures :
  1. 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)


Biospecimen Retention:   Samples Without DNA
teeth


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients aged between 13 and 17 years, who will be operated for wisdom tooth avulsion
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194451


Contacts
Contact: Vanessa MOBY, DD, PhD 0383154256 ext 33 vanessa.moby@univ-lorraine.fr

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

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03194451     History of Changes
Other Study ID Numbers: 2017-A00860-53/EUDRACT
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
bone tissue engineering, dental stem cell differentiation

Additional relevant MeSH terms:
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases