Bone Regeneration With Mesenchymal Stem Cells

Phase 3

Completed

• Conditions: Mandibular Fractures
• Interventions: Biological: Application of autologous mesenchymal stem cells

• Registration Number: NCT02755922
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Status Verified: 2016-04
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Study First Posted: 2016-04-29
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractures with Mesenchymal Stem Cells	Application of autologous 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.

Primary Outcome Measures

Name	Time	Method
Change of bone quality	from the moment of fracture diagnosis to week 4 and week 12 after surgery	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

Secondary Outcome Measures

Name	Time	Method
Number of patients with infection ( increase of local temperature, tenderness, leukocyte count >10,000/ µL, confirmed by Gram stain and blood culture).	from immediate postoperative period to three months after surgery	Infection suggested by clinical diagnosis increase of leukocyte levels, and confirmed by Gram stain and blood culture of local sample.
Number of patients with bleeding after surgery (Persistent bleeding, ineffectiveness stopping bleeding using dressings)	from immediate postoperative period to 1 week after surgery	Persistent bleeding after surgery, that did not stop by dressings. If this complication developed, it had to be managed by surgical techniques.
Number of patients with surgical wound dehiscence (subcutaneous tissue , bone or osteosynthesis material exposed and seen through opened skin )	from immediate postoperative period to one month	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.