Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy

Study Overview
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Brief Summary
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Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem cells are known as a effective therapy. In this study the investigators evaluate the side effect of bone marrow stem cell transplantation in patients with cerebral palsy.

Detailed Description
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Our study evaluate the side effects of bone marrow derived CD133 cells transplantation in 4-12years old patients with cerebral palsy.first all the patients undergone a comprehensive evaluation(physical exam, serology tests,EEG,MRI,GMFM66). After bone marrow aspiration,autologous stem cells prepare for each patient. In operation room ,the cells are transplanted by intrathecal injection. all the patients would be under observed to notice acute side effects and 3,6,9 and 12 months after injection they will be followed and evaluate by comprehensive tests.

Official Title
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Evaluation the Side Effects of Bone Marrow Derived CD133 Cells Transplantation in Cerebral Palsy Patients

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Biological: CD133 stem cell injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of spastic quadriplegic CP Children must be between the ages of 4 and 12 years Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees) Children must be seizure-free or seizure controlled Exclusion Criteria: Children who have a diagnosis of mixed types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia) Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months. Children who have a metallic or electrical implants

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stem cell recipients<br>The 4-12 years old patients with cerebral palsy who undergone bone marrow derived CD133 transplantation | Biological: CD133 stem cell injection<br>* Bone marrow derived CD133 stem cell witch are transplanted by intrathecal injection<br>* Other names: stem cell transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergic reaction | evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients | 1 month | 
| local infection | infections in site of injection | 1 month | 
| encephalitis | encephalitis due to cell transplantation | 1 month | 
| meningitis | meningitis due to cell trnsplantation | 1 month | 
| paralysis or sensory loss | paralysis or sensory loss below the level of the injection site | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| speech | evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy | 6 months | 
| motion | evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone marrow CD133 transplantation side effects, side effects