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Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation

This study is currently recruiting participants.
Verified April 2008 by Royan Institute
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01210950
First received: September 25, 2010
Last updated: December 25, 2012
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Leg Length Inequality
 Biological: cell and RPR injection
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • effect of mesenchymal cell transplantation to decrease limb inequal [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal


Secondary Outcome Measures:
  • improve life quality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    mesenchymal cells transplantation improve patients life quality


Estimated Enrollment: 6
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cell and RPR recepients
mesenchymal cells and plasma reach protein are injected to the callus center of short limb
 Biological: cell and RPR injection
mesenchymal cells and Plasma reach Protein are injected to the callus center
Other Name: cell therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210950

Contacts
Contact: Nasser Aghdami, MD,PhD +98-02122172332 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD +98-02122172332 leila.arab@yahoo.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD     +98-02122172332     nasser.aghdami@royaninstitute.org    
Contact: Leila Arab, MD     +98-02122172332     Leila.arab@yahoo.com    
Principal Investigator: Leila Taghiar, MSc            
Sub-Investigator: Reza Moghaddas Ali, MSc            
Sub-Investigator: Soura Mardpour, MSc            
Principal Investigator: Roghayeh Fazeli, MD            
Sub-Investigator: motalebi zadeh, MD            
Sponsors and Collaborators
Royan Institute
Investigators
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
  More Information

Additional Information:
Royan Institute  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01210950     History of Changes
Other Study ID Numbers: Royan-Bone-006
Study First Received: September 25, 2010
Last Updated: December 25, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
distraction
osteogenesis
limb length discrepancy
callus

Additional relevant MeSH terms:
Leg Length Inequality
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013