- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02900014
Validation of a Production Method of Stem Cell Isolated From the Nasal Cavity for an Innovative Cell Therapy of Cleft Palate
August 7, 2023 updated by: Assistance Publique Hopitaux De Marseille
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
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
- Name: Lucile FIEVET
- Email: lucile.fievet@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13005
- Assistance Publique Hopitaux de Marseille
-
-
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
No older than 6 months (Child)
Accepts Healthy Volunteers
No
Description
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
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
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Children with cleft
|
nasal mesenchymental stem cells are collected in patients with cleft undergoing general anesthesia, during the initial surgical management of cleft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of nasal mesenchymental stem cells
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Urielle DESALBRES, Assistance Publique Hopitaux de Marseille
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 (Actual)
September 18, 2015
Primary Completion (Actual)
September 22, 2015
Study Completion (Actual)
August 4, 2023
Study Registration Dates
First Submitted
September 9, 2016
First Submitted That Met QC Criteria
September 13, 2016
First Posted (Estimated)
September 14, 2016
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 7, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-12
- 2015-A00984-45 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Cleft Palate
-
Lagos State UniversityUniversity of Lagos, NigeriaRecruitingCleft Palate | Cleft Lip and Cleft Palate | Cleft Lip, Cleft Alveolus and Cleft PalateNigeria
-
UMC UtrechtRadboud University Medical Center; Academisch Medisch Centrum - Universiteit... and other collaboratorsRecruitingCleft Lip and Palate | Cleft Palate Children | Cleft Alveolar RidgeNetherlands
-
Cairo UniversityRecruitingCleft Lip and Palate | Bilateral Cleft Lip/PalateEgypt
-
Charles University, Czech RepublicAnthropology and Human Genetics; Otorhinolaryngology, 2nd Faculty of Medicine; Department of Newborns with Intensive Care UnitUnknownCleft Lip and Palate | Cleft Palate | Cleft Lip | Cleft Lip, BilateralCzechia
-
Children's Hospital of PhiladelphiaCompletedCleft Lip and Palate | Cleft Palate | Cleft LipUnited States
-
University Hospital, Basel, SwitzerlandInstitute of Mother and Child, Warsaw, PolandCompletedCleft Lip and Palate | Cleft Palate | Craniofacial DeformityPoland
-
University Hospital, Basel, SwitzerlandRecruitingCleft Lip and Palate | Cleft PalateSwitzerland
-
Duke UniversityEnrolling by invitationCleft Lip and Palate | Cleft Palate | Cleft LipUnited States, Canada
-
University Hospital, LilleUnknown
-
AZ Sint-Jan AVCompletedCleft Palate ChildrenBelgium
Clinical Trials on sampling mesenchymal stem cells
-
Guangzhou General Hospital of Guangzhou Military...UnknownSpinal Cord InjuryChina
-
Guangzhou General Hospital of Guangzhou Military...Guangzhou Municipal Twelfth People's Hospital; Guangdong Prevention and Treatment...Unknown
-
Guangzhou General Hospital of Guangzhou Military...UnknownParkinson's DiseaseChina
-
Hospital ZnojmoUnknown
-
National Research Center for Hematology, RussiaUnknownRelapse | Graft-versus-host DiseaseRussian Federation
-
University College, LondonUnknownTendinopathy | Achilles Tendinitis | Achilles Degeneration | Achilles Tendinitis, Right Leg | Achilles Tendon Thickening | Achilles Tendinitis, Left LegUnited Kingdom
-
Qingdao UniversityUnknownDilated CardiomyopathyChina
-
Qingdao UniversityUnknownUlcerative Colitis | Mesenchymal Stem Cells | Umbilical CordChina
-
Qingdao UniversityUnknownDiabetes Mellitus | Diabetes Mellitus, Type 1 | Mesenchymal Stem Cells | Umbilical CordChina
-
Universidad Catolica Santiago de GuayaquilMaastricht University Medical CenterUnknownOsteo Arthritis KneeEcuador