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Evaluation of Effect of Bone Marrow Aspirate Concentrate on Distracted Mandibular Bone Properties

NCT03861650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-03-04

No results posted yet for this study

Summary

Maxillofacial Distraction Osteogenesis (DO) has a lot of draw backs; mostly related to long distraction and consolidation time. Rapid rate DO was proposed to decrease the distraction time to avoid consequences of long procedure. The idea of the current study is to provide mesenchymal stem cells (MSCs) in form of Bone Marrow Aspirate Concentrate (BMAC) during rapid distraction to fasten and shorten consolidation. Methods: This trial was conducted on patients requiring mandibular DO. Patients were divided in two groups; control group in which distraction took place at a rate of 1.5 mm /day without any enhancement and study group in which distraction took place at rate of 1.5 mm /day and the distracted bone was enhanced by BMAC

Conditions

  • Hemifacial Microsomia
  • Distraction of Bone

Interventions

OTHER

Bone Marrow Aspirate Concentrate

A rich MSCs prepration made by centrifugation and concentration of aspirated bone marrow

OTHER

Saline

Physiological saline is added in control group to act as placebo

Sponsors & Collaborators

  • Yasser Mohamed Nabil Ahmed Khirat El Hadidi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-30
Primary Completion
2018-12-30
Completion
2018-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03861650 on ClinicalTrials.gov