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

NCT01958502 | Unknown Phase 2 DMC

• 1 other identifier: 910359
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

nonunion; mesenchymal stem cell; scaffold; BMP2; long bone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

mesenchymal stem cell

EXPERIMENTAL

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.

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

Interventions

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

mesenchymal stem cell

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emdadi Kamyab Hospital: lead
• National Taiwan University of Science and Technology: collaborator

Study Sites (1)

Emdai Kamyab Hospital

Mashhad, Khorasan, Iran

RECRUITING

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• mohammad taghi peivandi, MD

  Emdadi Kamyab Hospital

  PRINCIPAL INVESTIGATOR

• amin razi, MD

  Emdadi Kamyab Hospital

  STUDY DIRECTOR

Central Study Contacts

mohammad taghi peivandi, MD

CONTACT

+989153143691; peivandimt@mums.ac.ir

Amin razi, MD

CONTACT

+989153118713; aminra61@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: October 9, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 9, 2013

Record last verified: 2013-10

Locations

IR (1)