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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

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ClinicalTrials.gov Identifier: NCT01788059
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
mohammad taghi peivandi, Emdadi Kamyab Hospital

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. 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.

Condition or disease Intervention/treatment Phase
Nonunion Fracture Other: injection the mesenchymal stem cell in non union site Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital
Study Start Date : January 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

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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



Primary Outcome Measures :
  1. 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


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


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788059


Locations
Iran, Islamic Republic of
Emdai Kamyab Hospital
Mashhad, Khorasan, Iran, Islamic Republic of
Sponsors and Collaborators
Emdadi Kamyab Hospital
Investigators
Principal Investigator: mohammad taghi peivandi, MD Emdadi Kamyab Hospital

Responsible Party: mohammad taghi peivandi, MD, Emdadi Kamyab Hospital
ClinicalTrials.gov Identifier: NCT01788059     History of Changes
Other Study ID Numbers: 900939
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

Keywords provided by mohammad taghi peivandi, Emdadi Kamyab Hospital:
nonunion
mesenchymal stem cell
long bone

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Fractures, Ununited
Wounds and Injuries
Leg Injuries