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

NCT ID: NCT01958502

Last Updated: 2013-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-11-30

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. 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.

Conditions

Nonunion of Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mesenchymal stem cell

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.

Group Type: EXPERIMENTAL

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

Intervention Type: GENETIC

Interventions

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

Intervention Type: GENETIC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University of Science and Technology

OTHER

Sponsor Role: collaborator

Emdadi Kamyab Hospital

OTHER

Sponsor Role: lead

Responsible Party

mohammad taghi peivandi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mohammad taghi peivandi, MD

Role: PRINCIPAL_INVESTIGATOR

Emdadi Kamyab Hospital

amin razi, MD

Role: STUDY_DIRECTOR

Emdadi Kamyab Hospital

Locations

Emdai Kamyab Hospital

Mashhad, Khorasan, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

mohammad taghi peivandi, MD

Role: CONTACT

peivandimt@mums.ac.ir

+989153143691

Amin razi, MD

Role: CONTACT

aminra61@gmail.com

+989153118713

Facility Contacts

mohammad taghi peivandi, MD

Role: primary

peivandimt@mums.ac.ir

989153143691

amin razi, MD

Role: backup

aminra61@gmail.com

989153118713

Other Identifiers

910359

Identifier Type: -

Identifier Source: org_study_id