Tissue Engineered Constructs for Alveolar Cleft Repair

June 19, 2018 updated by: Walaa Kadry, Cairo University

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?

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

8 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion criteria

  • Bilateral alveolar clefts.
  • Cleft lip or palate not including the alveolus.
  • Immunocompromized patients.
  • Children who undergone previous bone grafting procedure for the alveolar cleft

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tissue engineered group
autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm)
Other: tissue engineered group
cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)
Other Names:
  • BM-MSCs on collagen matrix (Osteovit)
Active Comparator: autogenous bone graft group
autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm)
Procedure: autogenous bone graft group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediate postoperative and after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measuring the bone density on CT scan
Immediate postoperative and after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

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)

February 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 26, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSCs in alveolar cleft repair

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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