Clinical trial NCT02755922: Bone Regeneration With Mesenchymal Stem Cells
Official title: Bone Regeneration in Mandibular Fractures After the Application of Autologous Mesenchymal Stem Cells. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mandibular Fractures
Keywords: Mesenchymal Stem Cells
Treatment
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2016-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of bone quality
timeFrame: from the moment of fracture diagnosis to week 4 and week 12 after surgery
measure: Change of bone quality
timeFrame: from the moment of fracture diagnosis to week 4 and week 12 after surgery
Secondary outcomes:
measure: Number of patients with infection ( increase of local temperature, tenderness, leukocyte count >10,000/ µL, confirmed by Gram stain and blood culture).
timeFrame: from immediate postoperative period to three months after surgery
measure: Number of patients with bleeding after surgery (Persistent bleeding, ineffectiveness stopping bleeding using dressings)
timeFrame: from immediate postoperative period to 1 week after surgery
measure: Number of patients with surgical wound dehiscence (subcutaneous tissue , bone or osteosynthesis material exposed and seen through opened skin )
timeFrame: from immediate postoperative period to one month
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Alejandro Gonzalez Ojeda, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: