Nonunion of Fracture
Conditions
Keywords
nonunion, mesenchymal stem cell, scaffold, BMP2, long bone
Brief 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. Also for better result we used the mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is useful in filling the gap in non union site and irritate the union rate. Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure. 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.
Interventions
GENETICsurgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold
Sponsors
National Taiwan University of Science and Technology
Emdadi Kamyab Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical and radiological union at 1 month to 6 months | 6 months | patients receiving Mesenchymal Stem Cells within a 3-D tissue engineered scaffold that develop a partial or complete callus at 1, 2, 3, 4 ,5 and 6 months evaluate with standard X-rays |
Secondary
| Measure | Time frame |
|---|---|
| Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects(infection,malignancy,local or systemic allergic reaction) | 12 months |
Countries
Iran
Contacts
Primary Contactmohammad taghi peivandi, MD
Backup ContactAmin razi, MD
Outcome results
None listed