CompletedPhase 3

Bone Regeneration With Mesenchymal Stem Cells

20 participantsStarted 2010-04

Plain-language 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.

Who can participate

Age range

17 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of bone quality

Timeframe: from the moment of fracture diagnosis to week 4 and week 12 after surgery

Change of bone quality

Timeframe: from the moment of fracture diagnosis to week 4 and week 12 after surgery

Trial details

NCT IDNCT02755922

SponsorInstituto Mexicano del Seguro Social

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2010-09

View on ClinicalTrials.gov More Mandibular Fractures trials