Bone Regeneration With Mesenchymal Stem Cells

Instituto Mexicano del Seguro Social

Status and phase: Completed; Phase 3

Conditions: Mandibular Fractures

Treatments: Biological: Application of autologous mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02755922

2010-1301-27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 17 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Fractures with Mesenchymal Stem Cells

Experimental group

Description:

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

Treatment:

Biological: Application of autologous mesenchymal stem cells

Fractures without Mesenchymal Stem Cells

No Intervention group

Description:

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