Bone Regeneration With Mesenchymal Stem Cells

Mandibular Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755922
• Other study ID #: 2010-1301-27
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2016
• Last updated: April 26, 2016
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2016
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 59 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mandibular Fractures

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes