Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy

Conditions
-----------------
Leg Length Inequality

Intervention / Treatment
-----------------
* Biological: cell and RPR injection


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cell and RPR recepients<br>mesenchymal cells and plasma reach protein are injected to the callus center of short limb | Biological: cell and RPR injection<br>* mesenchymal cells and Plasma reach Protein are injected to the callus center<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distraction, osteogenesis, limb length discrepancy, callus