Cleft PalateNCT02900014
Validation of a Production Method of Stem Cell Isolated From the Nasal Cavity for an Innovative Cell Therapy of Cleft Palate
A study testing sampling mesenchymal stem cells in people with Cleft Palate, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Cleft Palate
- What is being tested?
- sampling mesenchymal stem cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2015to 4 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children with concomitant pathology that might alter bone turnover: osteogenesis imperfecta, kidney failure, chronic inflammatory diseases, infections, other diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cleft Palate
- Being tested
- sampling mesenchymal stem cells
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sampling mesenchymal stem cellsProcedure or surgery
nasal mesenchymental stem cells are collected in patients with cleft undergoing general anesthesia, during the initial surgical management of cleft
| Study group | Role | What they receive |
|---|---|---|
| Children with cleft | Experimental | Not described Receives: Procedure: sampling mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of nasal mesenchymental stem cells
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start18 Sep 2015
- Primary completion22 Sep 2015
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900014
- Sponsor's protocol ID
- 2015-12
- Other IDs
- 2015-A00984-45
- Status last verified
- Aug 2023
- First submitted
- 9 Sep 2016
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Production Method of Stem Cell Isolated From the Nasal Cavity for an Innovative Cell Therapy of Cleft Palate
- ClinicalTrials.gov ID
- NCT02900014
- Acronym / sponsor ID
- 2015-12
- Conditions
- Cleft Palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 18 Sep 2015 (actual)
- Primary completion
- 22 Sep 2015 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cleft | Experimental | Procedure: sampling mesenchymal stem cells |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Children with concomitant pathology that might alter bone turnover: osteogenesis imperfecta, kidney failure, chronic inflammatory diseases, infections, other diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sampling mesenchymal stem cellsnasal mesenchymental stem cells are collected in patients with cleft undergoing general anesthesia, during the initial surgical management of cleft | Procedure or surgery | Children with cleft |
Primary outcome
number of nasal mesenchymental stem cells
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Cleft Palate
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Furlow With Buccinator and Fistula Formation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle Desalbres study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sampling mesenchymal stem cells in people with Cleft Palate, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of nasal mesenchymental stem cells (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.