Bone Regeneration With Mesenchymal Stem Cells
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|ClinicalTrials.gov Identifier: NCT02755922|
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : April 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Mandibular Fractures||Biological: Application of autologous mesenchymal stem cells||Phase 3|
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 Type :||Interventional|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Bone Regeneration in Mandibular Fractures After the Application of Autologous Mesenchymal Stem Cells. Randomized Clinical Trial.|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||December 2010|
Experimental: 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.
Biological: 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
No Intervention: 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755922
|Principal Investigator:||Alejandro Gonzalez Ojeda, M.D., Ph.D.||Instituto Mexicano del Seguro Social|