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Evaluation the Treatment of Nonunion of Long Bone Fracture of Lower Extremities (Femur and Tibia) Using Mononuclear Stem Cells From the Iliac Wing Within a 3-D Tissue Engineered Scaffold

Sponsored by Emdadi Kamyab Hospital

About this trial

Last updated 13 years ago

Study ID

910359

Status

Unknown

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18 to 60 Years
All Sexes

Trial Timing

Ended 12 years ago

What is this trial about?

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.

What are the participation requirements?

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