Cleft Lip and PalateNCT01932164

Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients

A study testing maxillary alveolar graft by tissue engineering and Bone tissue engineering using mesenchymal stem cells in people with Cleft Lip and Palate, run by Hospital Sirio-Libanes at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and… Read more about this study

Who is it for?: Ages 7 to 12 years
Conditions the study is for: Cleft Lip and Palate
What is being tested?: maxillary alveolar graft by tissue engineering and Bone tissue engineering using mesenchymal stem cells
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteBrazil
Study dates: May 2013to 16 Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosis of unilateral cleft lip and palate ;
Patient who has performed the treatment to align the dental arches in the ambulatory of odontology at Hospital Municipal Infantil Menino Jesus;
Patient that have Goslow index 1, 2 or 3;
Patiente which have 2/3 of the root of the canine tooth (cleft region) formed.

Who cannot join

Prior alveolar surgery;
Canine teeth erupted before the bone graft;
Presence of co-morbidities;
Incomplete documentation;
Patients who have not done all the multidisciplinary treatment at Hospital Municipal Infantil Menino Jesus.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital Sírio Libanês
São Paulo, 01308-060

Other trials in Brazil

About this study

Read the detailed description

The reconstruction of the craniofacial skeleton in development between 2 and 10 years old, remains a major challenge for reconstructive plastic surgery. Local autogenous bone is practically unavailable, the distant bone graft has significant morbidity and use of alloplastic materials is incompatible with the growing facial skeleton. With the advent of bioengineered tissue, however, osteogenesis induced by the use of mesenchymal stem cells associated with biomaterials has become a potential solution to the shortage bone-related morbidity and donor bone in the region in pediatric patients.

The association of mesenchymal stem cells to biomaterials has provided new bone formation and a significant reduction of morbidity, for rehabilitation of the alveolar bone in patients with cleft lip palate.

To perform the rehabilitation of alveolar bone cleft, other donor regions of bone (iliac crest, ribs, skull) suffer morbidity for obtaining bone to be used in alveolar bone grafting. In order to eliminate the morbidity at the bone donor region for these patients and reduce costs of patient permanence in the operating room the aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and quantitative analysis of bone neoformation.

Conditions: Cleft Lip and Palate
Being tested: maxillary alveolar graft by tissue engineering, Bone tissue engineering using mesenchymal stem cells
Keywords: Cleft lip and palate, Deciduous dental pulp stem cells, mesenchymal stem cells, tissue engineering, bone tissue engineering, bioengineering
Medical subject headings: Cleft Lip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

maxillary alveolar graft by tissue engineeringProcedure or surgery
Also called alveolar bone graft, bone tissue engineering, bone tissue engineering using mesenchymal stem cells
Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;
Bone tissue engineering using mesenchymal stem cellsProcedure or surgery
Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.

Study groups in NCT01932164
Study group	Role	What they receive
cleft lip and palate	Experimental	5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery Receives: Procedure: maxillary alveolar graft by tissue engineering; Procedure: Bone tissue engineering using mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Amount of New Bone Mass Formed
The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.
Measured: 6 months from surgical procedure for alveolar grafting;
Quality of Bone Regeneration
The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.
Measured: Three months after the graft

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201316 Dec 2015

First posted30 Aug 2013 (estimated)
Study startMay 2013
Primary completion16 Dec 2015
Study completion16 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01932164
Sponsor's protocol ID: HSL 2013-04
Status last verified: May 2020
First submitted: 27 Aug 2013
Last updated: 28 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hibi H, Yamada Y, Ueda M, Endo Y. Alveolar cleft osteoplasty using tissue-engineered osteogenic material. Int J Oral Maxillofac Surg. 2006 Jun;35(6):551-5. doi: 10.1016/j.ijom.2005.12.007. Epub 2006 Apr 11.
PubMed 16584868
Gimbel M, Ashley RK, Sisodia M, Gabbay JS, Wasson KL, Heller J, Wilson L, Kawamoto HK, Bradley JP. Repair of alveolar cleft defects: reduced morbidity with bone marrow stem cells in a resorbable matrix. J Craniofac Surg. 2007 Jul;18(4):895-901. doi: 10.1097/scs.0b013e3180a771af.
PubMed 17667684
Tanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020.
PubMed 32256610

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
Enrolling by invitation
Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip
Cleft Palate +/- Lip

All Cleft Lip and Palate trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
ClinicalTrials.gov ID: NCT01932164
Acronym / sponsor ID: HSL 2013-04
Conditions: Cleft Lip and Palate
Keywords: Cleft lip and palate, Deciduous dental pulp stem cells, mesenchymal stem cells, tissue engineering, bone tissue engineering, bioengineering
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Hospital Sirio-LibanesUniversity, hospital or other
Collaborators: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Study start: May 2013 (actual)
Primary completion: 16 Dec 2015 (actual)
Study completion: 16 Dec 2015 (actual)
First posted: 30 Aug 2013 (estimated)
Results: Posted 30 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
cleft lip and palate	Experimental	Procedure: maxillary alveolar graft by tissue engineering, Procedure: Bone tissue engineering using mesenchymal stem cells5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery

Who may qualify

Ages: 7 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Diagnosis of unilateral cleft lip and palate ;
Patient who has performed the treatment to align the dental arches in the ambulatory of odontology at Hospital Municipal Infantil Menino Jesus;
Patient that have Goslow index 1, 2 or 3;
Patiente which have 2/3 of the root of the canine tooth (cleft region) formed.

Key exclusion criteria (5 listed)

Prior alveolar surgery;
Canine teeth erupted before the bone graft;
Presence of co-morbidities;
Incomplete documentation;
Patients who have not done all the multidisciplinary treatment at Hospital Municipal Infantil Menino Jesus.

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
maxillary alveolar graft by tissue engineeringAlso: alveolar bone graft, bone tissue engineering, bone tissue engineering using mesenchymal stem cellsExtraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;	Procedure or surgery	cleft lip and palate
Bone tissue engineering using mesenchymal stem cellsSecondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.	Procedure or surgery	cleft lip and palate

Primary outcome

Amount of New Bone Mass Formed
Time frame: 6 months from surgical procedure for alveolar grafting;
The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.
Quality of Bone Regeneration
Time frame: Three months after the graft
The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.

Results and safety

Results posted to the registry on 30 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cleft Lip and Palate	5	5

Primary outcome: Amount of New Bone Mass Formed

Time frame: 6 months from surgical procedure for alveolar grafting;. Mean (95% Confidence Interval). Unit: percentage of bone formation

Measure	Cleft Lip and Palate n = 5
Value	89 (89 to 100)

Population analysed: 3 females and 2 males with cleft lip and palate

Primary outcome: Quality of Bone Regeneration

Time frame: Three months after the graft. Mean (80% Confidence Interval). Unit: percentage of bone filling

Measure	Cleft Lip and Palate n = 5
Value	90 (80 to 100)

Adverse events

Time frame: The adverse event data were collected on days 15th, 1 month, 6 months and 12 months of all 5 patients.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cleft Lip and Palate	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16584868Hibi H, Yamada Y, Ueda M, Endo Y. Alveolar cleft osteoplasty using tissue-engineered osteogenic material. Int J Oral Maxillofac Surg. 2006 Jun;35(6):551-5. doi: 10.1016/j.ijom.2005.12.007. Epub 2006 Apr 11.
Background: PubMed 17667684Gimbel M, Ashley RK, Sisodia M, Gabbay JS, Wasson KL, Heller J, Wilson L, Kawamoto HK, Bradley JP. Repair of alveolar cleft defects: reduced morbidity with bone marrow stem cells in a resorbable matrix. J Craniofac Surg. 2007 Jul;18(4):895-901. doi: 10.1097/scs.0b013e3180a771af.
Derived from this study: PubMed 32256610Tanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020.

Related trials for Cleft Lip and Palate

Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
Enrolling by invitation
Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip
Cleft Palate +/- Lip

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.

Daniela F Bueno, PhD principal investigator

Hospital Sirio-Libanes

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 5 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 28 May 2020. 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 Brazil. 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?

Yes. Results are posted in the registry (first posted 30 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Amount of New Bone Mass Formed (time frame: 6 months from surgical procedure for alveolar grafting;). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01932164, which also lists 3 linked publications.

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 28 May 2020.