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

Sponsor

Emdadi Kamyab Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01958502

Collaborator

National Taiwan University of Science and Technology (Other)

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nonunion of Fracture	Genetic: surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jul 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mesenchymal stem cell 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.	Genetic: surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold

Arm

Intervention/Treatment

Experimental: mesenchymal stem cell

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.

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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