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Evaluation the Treatment of Nonunion of Long Bone Fracture of Lower Extremities (Femur and Tibia) Using Mononuclear Stem Cells From the Iliac Wing Within a 3-D Tissue Engineered Scaffold

NCT01958502 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-10-09

No results posted yet for this study

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. Also for better result we used the mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is useful in filling the gap in non union site and irritate the union rate.

Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure. 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.

Conditions

  • Nonunion of Fracture

Interventions

GENETIC

surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold

Sponsors & Collaborators

  • National Taiwan University of Science and Technology

    collaborator OTHER

  • Emdadi Kamyab Hospital

    lead OTHER

Principal Investigators

  • mohammad taghi peivandi, MD · Emdadi Kamyab Hospital

  • amin razi, MD · Emdadi Kamyab Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2014-11-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01958502 on ClinicalTrials.gov