CompletedPhase 2

The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital

Iran19 participantsStarted 2013-01

Plain-language summary

Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union on the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment.clinical union consider to relief pain in non union site and be stable in examination.

Who can participate

Age range

18 Years – 60 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: * Every patient with non union in the site of long bone fracture * Age more than 18 and under 60 years old * Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction. * No infection in site of surgery * Be able and willing to participate in the study * Written informed consent Exclusion Criteria: * Evidence of malignancy * Pregnancy or breastfeeding * Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing

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

clinical and radiological union at 1 month to 6 months

Timeframe: 6 months

Trial details

NCT IDNCT01788059

SponsorEmdadi Kamyab Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-10

View on ClinicalTrials.gov More Nonunion Fracture trials