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

Nonunion of Fracture Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01958502
• Other study ID #: 910359
• Status: Recruiting
• Phase: Phase 2
• First received: August 21, 2013
• Last updated: October 8, 2013
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: October 2013
• Source: Emdadi Kamyab Hospital
• Contact: mohammad taghi peivandi, MD
• Phone: +989153143691
• Email: peivandimt[@]mums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Ununited
• Nonunion of Fracture

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Emdadi Kamyab Hospital	National Taiwan University of Science and Technology

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 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	6 months	Yes
Secondary	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	Yes