Clinical Trial: Bone Regeneration With Mesenchymal Stem Cells

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Instituto Mexicano del Seguro Social

Current Primary Outcome:

• Change of bone quality [ Time Frame: from the moment of fracture diagnosis to week 4 and week 12 after surgery ]
  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
• Change of bone quality [ Time Frame: 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of patients with infection ( increase of local temperature, tenderness, leukocyte count >10,000/ µL, confirmed by Gram stain and blood culture). [ Time Frame: 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) [ Time Frame: 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 ) [ Time Frame: 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.

Original Secondary Outcome: Same as current

Information By: Instituto Mexicano del Seguro Social

Dates:
Date Received: April 20, 2016
Date Started: April 2010
Date Completion:
Last Updated: April 26, 2016
Last Verified: April 2016