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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


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Nonunion Fracture

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinical and radiological union at 1 month to 6 months

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

mohammad taghi peivandi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emdadi Kamyab Hospital

Authority:

Iran: Ministry of Health

Study ID:

900939

NCT ID:

NCT01788059

Start Date:

January 2013

Completion Date:

May 2014

Related Keywords:

  • Nonunion Fracture
  • nonunion
  • mesenchymal stem cell
  • long bone
  • Femoral Fractures
  • Fractures, Bone
  • Fractures, Ununited

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