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Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01210950
First Posted: September 29, 2010
Last Update Posted: April 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royan Institute
September 25, 2010
September 29, 2010
April 28, 2014
September 2009
December 2013   (Final data collection date for primary outcome measure)
effect of mesenchymal cell transplantation to decrease limb inequal [ Time Frame: 6 months ]
evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal
effect of mesenchymal cell transplantation in limb lengthening [ Time Frame: 6 months ]
evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening
Complete list of historical versions of study NCT01210950 on ClinicalTrials.gov Archive Site
improve life quality [ Time Frame: 12 months ]
mesenchymal cells transplantation improve patients life quality
Same as current
Not Provided
Not Provided
 
Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation
Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy
Limb-length discrepancy can be due to many causes. These are divided into three groups: congenital (from birth), developmental (from a childhood disease or injury that slows or damages the growth plates), and posttraumatic (from a fracture that leads to shortening of the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in), shortening of the long leg can be considered, especially for tall persons. For growing children, this can be easily accomplished with a small, minimally invasive, uncomplicated procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow derived mesenchymal stem cells can shorten the treatment period by acceleration of bone regeneration during distraction osteogenesis.
Distraction osteogenesis has been widely utilized to treat leg length discrepancy, deformity, nonunion, osteomyelitis, and bone loss. It has been found that most difficult conditions can be resolved with this method. In this study the aim is to observe if mesenchymal stem cell transplantation can enhance new bone formation during distraction osteogenesis.Patients undergo bone distraction , and about 2-3 weeks after distraction mesenchymal stem cell are injected at the callus site. In the case of large bone gap, mesenchymal stem cells are seeded on bone matrix and then placed in the bone gap. Each patient is assessed at interval time of 1 month for 6 months post surgery by X-Ray and at month 6 post surgery by computed tomography(CT) scans.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Leg Length Inequality
Biological: cell and RPR injection
mesenchymal cells and Plasma reach Protein are injected to the callus center
Other Name: cell therapy
Experimental: cell and RPR recepients
mesenchymal cells and plasma reach protein are injected to the callus center of short limb
Intervention: Biological: cell and RPR injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • both gender
  • patient with limb-length discrepancy
  • Age:18-65

Exclusion Criteria:

  • Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease
  • Known allergic reaction to components of study treatment and/or study injection procedure
  • Patients infected with hepatitis B,C or HIV
  • pregnancy
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01210950
Royan-Bone-006
Yes
Not Provided
Not Provided
Royan Institute
Royan Institute
Not Provided
Study Chair: Hamid Gourabi, PhD President of Royan Institute
Study Director: Mohammad reza Baghban Eslami Nejad, PhD Board scientific
Principal Investigator: Mohssen Emadeddin, MD Orthopadic Investigator
Principal Investigator: Nasser Aghdami, MD,PhD Head of Regenerative center
Royan Institute
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP