The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital

Emdadi Kamyab Hospital19 enrolled

Overview

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. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. 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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nonunion Fracture

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

clinical and radiological union at 1 month to 6 months

patients receiving Mesenchymal Stem Cells that develop a partial or complete callus at 1, 2, 3, 4 ,5 and 6 months evaluate with standard X-rays

Time frame: 6 months

Secondary Outcomes

•Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects.

Time frame: 12 months

Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored