Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861650
Recruitment Status : Completed
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Yasser Mohamed Nabil Ahmed Khirat El Hadidi, Ain Shams University

Brief 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

Condition or disease Intervention/treatment Phase
Hemifacial Microsomia Distraction of Bone Other: Bone Marrow Aspirate Concentrate Other: Saline Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Case-control trial
Masking: Double (Participant, Care Provider)
Masking Description: Single blinded
Primary Purpose: Treatment
Official Title: The Effect of Bone Marrow Aspirate Concentrate on Bone Regenerate During Rapid Mandibular Distraction Osteogensis
Actual Study Start Date : December 30, 2015
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018


Arm Intervention/treatment
Experimental: Bone Marrow Aspirate Concentrate
Bone Marrow Aspirate Concentrate is prepared from bone marrow by aspiration by wide bore needle and then prepared by centrifugation to get rich mix of MSCs to improve healing
Other: Bone Marrow Aspirate Concentrate
A rich MSCs prepration made by centrifugation and concentration of aspirated bone marrow

Sham Comparator: Saline
Sham or placebo drug in the control group
Other: Saline
Physiological saline is added in control group to act as placebo




Primary Outcome Measures :
  1. Assessment of effect of BMAC on rapidly distracted bone quality [ Time Frame: 6 months ]
    radiographically the bone density was assessed using CBCT of the patients to evaluate the effect of BMAC on bone maturation in term of increased bone density measured in Hounsfield unit as the increase in bone density indicates better healing and more bone maturation and justify addition of BMAC



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients free from any disease affecting bone formation of both sexes was included in the study.
  2. Patients younger than 25 years old.
  3. Patients included in the study were post traumatic patients, hemifacial microsomia, Treacher Collins and post ankylotic mandibular deformity.
  4. Distraction range was between 15-20 mm.

Exclusion Criteria:

  1. The presence of uncontrolled systemic disease.
  2. Previous radiotherapy on head and neck region.
  3. Chemotherapy within the past 12-month period.
  4. An active infection at the distraction site.

Layout table for additonal information
Responsible Party: Yasser Mohamed Nabil Ahmed Khirat El Hadidi, Assistant Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03861650     History of Changes
Other Study ID Numbers: 392
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yasser Mohamed Nabil Ahmed Khirat El Hadidi, Ain Shams University:
bone marrow aspirate concentrate
Hemifacial Microsomia
Distraction osteogenesis
Additional relevant MeSH terms:
Layout table for MeSH terms
Goldenhar Syndrome
Diastasis, Bone
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Mandibulofacial Dysostosis
Craniofacial Dysostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities
Joint Dislocations
Joint Diseases
Wounds and Injuries