Bone Regeneration With Mesenchymal Stem Cells

Study Overview
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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.

Official Title
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Bone Regeneration in Mandibular Fractures After the Application of Autologous Mesenchymal Stem Cells. Randomized Clinical Trial.

Conditions
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Mandibular Fractures

Intervention / Treatment
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* Biological: Application of autologous mesenchymal stem cells


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractures with Mesenchymal Stem Cells<br>10 patients with mandibular fractures were managed by open reduction and internal fixation, with application of autologous mesenchymal stem cells on the fracture site. | Biological: Application of autologous mesenchymal stem cells<br>* 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<br>|
| No Intervention: Fractures without Mesenchymal Stem Cells<br>10 patients with mandibular fractures were managed by open reduction and internal fixation, without application of autologous mesenchymal stem cells on the fracture site. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of bone quality | After the procedure, imaging control by X-ray and analysis by software, was done after surgery at weeks 4 and 12. X- ray units: Voxels. Software analysis by Image Processing and Analysis ImageJ 1.43 | from the moment of fracture diagnosis to week 4 and week 12 after surgery | 
| Change of bone quality | After the procedure, imaging control by CT scan and analysis by software, was done after surgery at weeks 4 and 12. CT scan units: Hounsfiled . Software analysis by Image Processing and Analysis ImageJ 1.43 | from the moment of fracture diagnosis to week 4 and week 12 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with infection ( increase of local temperature, tenderness, leukocyte count >10,000/ µL, confirmed by Gram stain and blood culture). | Infection suggested by clinical diagnosis increase of leukocyte levels, and confirmed by Gram stain and blood culture of local sample. | from immediate postoperative period to three months after surgery | 
| Number of patients with bleeding after surgery (Persistent bleeding, ineffectiveness stopping bleeding using dressings) | Persistent bleeding after surgery, that did not stop by dressings. If this complication developed, it had to be managed by surgical techniques. | from immediate postoperative period to 1 week after surgery | 
| Number of patients with surgical wound dehiscence (subcutaneous tissue , bone or osteosynthesis material exposed and seen through opened skin ) | Clinical signs of dehiscence on the surgical incision, surgical material or bone seen though the skin. This diagnosis is done by clinical findings. Does not need any laboratory or image test. | from immediate postoperative period to one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesenchymal Stem Cells, Treatment