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Bone Regeneration With Mesenchymal Stem Cells

NCT ID: NCT02755922

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

Brief Summary

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Mandible fractures are a common cause of facial injury in adults. The autologous mesenchymal stem cell (AMSC) transplantation, is proposed as an alternative to the conventional graft treatment, improving bone neoformation.The objective was to evaluate the effectiveness of AMSCs application in mandibular fractures to reduce regeneration time and increase bone quality.

Detailed Description

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Single blinded controlled clinical trial in patients with mandibular angle fracture. The patients were divided into: Study Group (SG): fracture reduction plus application of AMSCs, Control Group (CG): Same procedure without AMSCs. AMSCs were obtained from adipose tissue , 24 hrs before the procedure. Intensity and density were evaluated in normal bone and fractured bone, at 4 and 12 weeks after surgery using panoramic radiography and computed tomography. (CT)

A total of 20 patients, 10 in each group were included. SG with a mean age of 31.2 ± 6.3 years and CG 29.7 ± 7.2 years, all patients were male. Bone quality at week 4 SG 108.82 ± 3.4 vs CG 93.92 ± 2.6 (p = 0.000) by panoramic radiography, SG 123 ± 4.53 vs CG 99.72 ± 5.72 (p = 0.000) by CT. At week 12: SG 153.53±1.83 vs CG 101.81±4.83 (p= 0.000) by panoramic radiography, SG 165.4 ± 4.2 vs CG 112.05±2.1 (p= 0.000) by CT.

The application of AMSCs presented at week 4 similar ossification values compared with normal bone and a 36.48 % higher ossification rate at week 12.

Conditions

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Mandibular Fractures

Keywords

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Mesenchymal Stem Cells Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fractures with Mesenchymal Stem Cells

10 patients with mandibular fractures were managed by open reduction and internal fixation, with application of autologous mesenchymal stem cells on the fracture site.

Group Type EXPERIMENTAL

Application of autologous mesenchymal stem cells

Intervention Type BIOLOGICAL

within the surgical procedure, mesenchymal stem cells, were applied on the fracture site. Imaging by X-ray and CT and imaging analysis was done after fracture repair, at week 4 and week 12

Fractures without Mesenchymal Stem Cells

10 patients with mandibular fractures were managed by open reduction and internal fixation, without application of autologous mesenchymal stem cells on the fracture site.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Application of autologous mesenchymal stem cells

within the surgical procedure, mesenchymal stem cells, were applied on the fracture site. Imaging by X-ray and CT and imaging analysis was done after fracture repair, at week 4 and week 12

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Entitled patients to the Mexican Institute of Social Security
* Patients with mandibular condyle fractures associated or not to other initial fracture that required Open reduction and internal fixation
* Ages from 17 to 59 years
* Both female and male gender
* Patients who gave their consent to be part of this trial

Exclusion Criteria

* Patients younger than 17 years and older than 59 years
* Chronic-degenerative diseases, active smoking, collagen disorders
* Patients with signs of infection in the aimed area to treat and in whom the fracture occurred in a longer period than 10 days before their surgery.
Minimum Eligible Age

17 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alejandro Gonzalez-Ojeda

M.D.,Ph.D., F.A.C.S.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alejandro Gonzalez Ojeda, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Other Identifiers

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2010-1301-27

Identifier Type: -

Identifier Source: org_study_id