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

Nonunion Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788059
• Other study ID #: 900939
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2013
• Last updated: December 26, 2013
• Start date: January 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Emdadi Kamyab Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Fractures, Ununited
• Nonunion Fracture

Intervention

Other:
• injection the mesenchymal stem cell in non union site

Locations

Country	Name	City	State
Iran, Islamic Republic of	Emdai Kamyab Hospital	Mashhad	Khorasan

Sponsors (1)

Lead Sponsor	Collaborator
Emdadi Kamyab Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	•Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects.		12 months
Secondary	Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored		12 months