Cleft Lip and PalateNCT03563495
Tissue Engineered Constructs for Alveolar Cleft Repair
A study testing tissue engineered group and autogenous bone graft group in people with Cleft Lip and Palate, run by Cairo University.
Trial summary
Description of the research question In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting? Objective of the study: Research hypothesis The tissue engineered constructs will… Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- tissue engineered group and autogenous bone graft group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Sep 2017
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with maxillary unilateral alveolar clefts requiring reconstruction
- Children free from any systemic disease that may affect normal healing of bone
- Children in an age range (8-14) year.
Who cannot join
- Bilateral alveolar clefts.
- Cleft lip or palate not including the alveolus.
- Immunocompromized patients.
- Children who undergone previous bone grafting procedure for the alveolar cleft
About this study
Official title: Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)
Description of the research question
In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting?
Read more
Objective of the study:
- Research hypothesis
The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction.
- The objectives
The primary objective:
Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.
The secondary objective:
Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.
- Conditions
- Cleft Lip and Palate
- Being tested
- tissue engineered group, autogenous bone graft group
- Keywords
- tissue engineering., stem cells., autogenous grafts.
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue engineered groupOther
Also called BM-MSCs on collagen matrix (Osteovit)
cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)
autogenous bone graft groupProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| tissue engineered group | Active comparator | autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm) Receives: Other: tissue engineered group |
| autogenous bone graft group | Active comparator | autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm) Receives: Procedure: autogenous bone graft group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months
Measuring the bone volume on CT scan
Measured: Immediate postoperative and after 6 months
Secondary outcomes (1)
Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months
Measuring the bone density on CT scan
Measured: Immediate postoperative and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study startFeb 2015
- Primary completionJul 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Kadry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563495
- Sponsor's protocol ID
- MSCs in alveolar cleft repair
- Status last verified
- Jun 2018
- First submitted
- 26 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT03563495
- Acronym / sponsor ID
- MSCs in alveolar cleft repair
- Conditions
- Cleft Lip and Palate
- Keywords
- tissue engineering., stem cells., autogenous grafts.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 20 Jun 2018 (actual)
- 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.
Description of the research question
In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting?
Objective of the study:
- Research hypothesis
The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction.
- The objectives
The primary objective:
Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.
The secondary objective:
Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tissue engineered group | Active comparator | Other: tissue engineered groupautogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm) |
| autogenous bone graft group | Active comparator | Procedure: autogenous bone graft groupautogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm) |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with maxillary unilateral alveolar clefts requiring reconstruction
- Children free from any systemic disease that may affect normal healing of bone
- Children in an age range (8-14) year.
Key exclusion criteria (4 listed)
- Bilateral alveolar clefts.
- Cleft lip or palate not including the alveolus.
- Immunocompromized patients.
- Children who undergone previous bone grafting procedure for the alveolar cleft
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 |
|---|---|---|
| tissue engineered groupAlso: BM-MSCs on collagen matrix (Osteovit)cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit) | Other | tissue engineered group |
| autogenous bone graft group | Procedure or surgery | autogenous bone graft group |
Primary outcome
Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months
Time frame: Immediate postoperative and after 6 months
Measuring the bone volume on CT scan
1 secondary outcome
Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months
Time frame: Immediate postoperative and after 6 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 20 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tissue engineered group and autogenous bone graft group in people with Cleft Lip and Palate, run by Cairo University.
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 3 inclusion and 4 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months (time frame: Immediate postoperative and after 6 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 20 Jun 2018.