Trial | NCT01958502  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    mesenchymal stem cells with bmp2 ...

  • Study Participants

    18
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.
Study Started
Jul 31
2013
Primary Completion
Jul 31
2014
Anticipated
Study Completion
Nov 30
2014
Anticipated
Last Update
Oct 09
2013
Estimate

Genetic surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold

mesenchymal stem cell Experimental

stem cells drived from iliac bone marrow with centrifuge and ficoll method then implant in collagenic 3-D scaffold with BMP-2 and put in non union site by surgical approach under general or spinal anesthesia as deemed appropriate by the anesthetist.

Criteria 

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
No Results Posted