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Trial record 63 of 799 for:    Interventional Studies | mesenchymal

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
Sponsor:
Information provided by (Responsible Party):
Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social

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.

Condition or disease Intervention/treatment Phase
Mandibular Fractures Biological: Application of autologous mesenchymal stem cells Phase 3

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.


Study Type : Interventional
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   17 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Alejandro Gonzalez Ojeda, M.D., Ph.D. Instituto Mexicano del Seguro Social

Responsible Party: Alejandro Gonzalez-Ojeda, M.D.,Ph.D., F.A.C.S., Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02755922     History of Changes
Other Study ID Numbers: 2010-1301-27
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social:
Mesenchymal Stem Cells
Treatment

Additional relevant MeSH terms:
Mandibular Fractures
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Fractures, Bone
Wounds and Injuries