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 range18 Years – 60 Years

SexALL

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

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