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

Phase 2

Completed

• Conditions: Nonunion Fracture
• Interventions: Other: injection the mesenchymal stem cell in non union site

• Registration Number: NCT01788059
• Lead Sponsor: Emdadi Kamyab Hospital

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-26
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cell	injection the mesenchymal stem cell in non union site	stem cells drived from iliac bone marrow with centrifuge and ficoll method then inject to non union site 2-3 ml with approximately 40 X 10E6 Mesenchymal Stem Cells (MSC) will be injected in the nonunion site of the bone fracture under fluoroscopic gide and general or spinal anesthesia as deemed appropriate by the anesthetist.

Primary Outcome Measures

Name	Time	Method
clinical and radiological union at 1 month to 6 months	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

Secondary Outcome Measures

Name	Time	Method
•Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects.	12 months
Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored	12 months

Trial Locations

Locations (1)

Emdai Kamyab Hospital; 🇮🇷 Mashhad, Khorasan, Iran, Islamic Republic of