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Completed

NCT Number: NCT01788059

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

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Key information

Conditions

Nonunion Fracture Fractures, Bone Fractures, Ununited Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emdai Kamyab Hospital

Mashhad, Khorasan, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

injection the mesenchymal stem cell in non union site

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Emdadi Kamyab Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2013
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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