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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Detailed Description

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Conditions

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Nonunion of Fracture

Keywords

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nonunion mesenchymal stem cell scaffold BMP2 long bone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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

Intervention Type GENETIC

Eligibility Criteria

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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

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National Taiwan University of Science and Technology

OTHER

Sponsor Role collaborator

Emdadi Kamyab Hospital

OTHER

Sponsor Role lead

Responsible Party

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mohammad taghi peivandi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mohammad taghi peivandi, MD

Role: PRINCIPAL_INVESTIGATOR

Emdadi Kamyab Hospital

amin razi, MD

Role: STUDY_DIRECTOR

Emdadi Kamyab Hospital

Locations

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Emdai Kamyab Hospital

Mashhad, Khorasan, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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mohammad taghi peivandi, MD

Role: CONTACT

Phone: +989153143691

Email: [email protected]

Amin razi, MD

Role: CONTACT

Phone: +989153118713

Email: [email protected]

Facility Contacts

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mohammad taghi peivandi, MD

Role: primary

amin razi, MD

Role: backup

Other Identifiers

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910359

Identifier Type: -

Identifier Source: org_study_id