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

December 26, 2013 updated by: mohammad taghi peivandi, Emdadi Kamyab Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: injection the mesenchymal stem cell in non union site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical and radiological union at 1 month to 6 months
Time Frame: 6 months
patients receiving Mesenchymal Stem Cells that develop a partial or complete callus at 1, 2, 3, 4 ,5 and 6 months evaluate with standard X-rays
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
•Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects.
Time Frame: 12 months
12 months
Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emdadi Kamyab Hospital

Investigators

  • Principal Investigator: mohammad taghi peivandi, MD, Emdadi Kamyab Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (ESTIMATE)

February 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 26, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 900939

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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