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

Emdadi Kamyab Hospital

Status and phase: Unknown; Phase 2

Conditions: Nonunion of Fracture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01958502

910359

Details and patient eligibility

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

mesenchymal stem cell

Experimental group

Description:

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.

Treatment:

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