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.

Study Overview

• Status: Completed
• Conditions: Leg Length Inequality
• Intervention / Treatment: Biological: cell and RPR injection

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: cell therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of mesenchymal cell transplantation to decrease limb inequal	evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improve life quality	mesenchymal cells transplantation improve patients life quality	12 months

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Chair: hamid gourabi, PhD, President of Royan Institute; Principal Investigator: Nasser Aghdami, MD,PhD, Head of Regenerative center; Study Director: Mohammad reza Baghban Eslami Nejad, PhD, Board scientific

Publications and helpful links

Helpful Links

• Royan Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 25, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Estimate): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: distraction; osteogenesis; limb length discrepancy; callus
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Bone Diseases, Developmental; Leg Length Inequality
• Other Study ID Numbers: Royan-Bone-006