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

NCT ID: NCT01788059

Last Updated: 2013-12-30

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-11-30

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. 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.

Detailed Description

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Conditions

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Nonunion Fracture

Keywords

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nonunion mesenchymal stem cell 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 inject to non union site 2-3 ml with approximately 40 X 10E6 Mesenchymal Stem Cells (MSC) will be injected in the nonunion site of the bone fracture under fluoroscopic gide and general or spinal anesthesia as deemed appropriate by the anesthetist.

Group Type EXPERIMENTAL

injection the mesenchymal stem cell in non union site

Intervention Type OTHER

Interventions

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injection the mesenchymal stem cell in non union site

Intervention Type OTHER

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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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

Locations

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Emdai Kamyab Hospital

Mashhad, Khorasan, Iran

Site Status

Countries

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Iran

Other Identifiers

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900939

Identifier Type: -

Identifier Source: org_study_id