Bone Regeneration With Mesenchymal Stem Cells

NCT02755922 | Completed Phase 3 DMC

• 1 other identifier: 2010-1301-27
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mandibular Fractures

Keywords

Mesenchymal Stem Cells; Treatment

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

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

  from immediate postoperative period to three months after surgery

• Number of patients with bleeding after surgery (Persistent bleeding, ineffectiveness stopping bleeding using dressings)

  from immediate postoperative period to 1 week after surgery

• Number of patients with surgical wound dehiscence (subcutaneous tissue , bone or osteosynthesis material exposed and seen through opened skin )

  from immediate postoperative period to one month

Study Arms (2)

Fractures with Mesenchymal Stem Cells

EXPERIMENTAL

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

Fractures without Mesenchymal Stem Cells

NO INTERVENTION

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

Interventions

Application of autologous mesenchymal stem cells BIOLOGICAL

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

Fractures with Mesenchymal Stem Cells

Eligibility Criteria

• Age: 17 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Alejandro Gonzalez Ojeda, M.D., Ph.D.

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,Ph.D., F.A.C.S.

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 29, 2016
• Study Start: April 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share