Multiple Transplantation of Bone Marrow Derived CD133 Cell 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 multiple intrathecal injection of bone marrow stem cell in patients with cerebral palsy.

Detailed Description
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In this study,we evaluate the safety of multiple transplantation of bone marrow derived stem cells.the children(4-12years)with definite diagnose of cerebral palsy enroll to the study.first of all all the physical exam,laboratory test,EEG and MRI is done.after hospital admission,the patient underwent bone marrow transplantation.In laboratory,the cells are separated and prepared for injection.after 24hours the neurosurgeon inject the cells(intrathecal).the patient would be under observed for 48hours.If no allergic reaction or abnormal neurological symptoms accrued,patients can be discharged and would be followed up 1,3 and 6months after injection.at the end of the 6months,the patients would receive second injection as same as the previous process.then they are followed at 1,3 immediate local and systemic side effect(fever,respiratory distress,erythema,rash,increase of heart rate or blood pressure)and neurological symptoms:motor dysfunction,sensory dysfunction,sphincter dysfunction,nausea,vomiting,head ache.EEG,MRI,GMFM66

Official Title
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The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Biological: stem cell intrathecal injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD133 transplantation<br>The patients with cerebral palsy that underwent CD133 transplantation. | Biological: stem cell intrathecal injection<br>* Intrathecal injection of Bone marrow derived CD133 cells<br>* Other names: Stem cell transplantation;|
| No Intervention: Control<br>The patients with cerebral palsy that underwent regular observation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motor dysfunction | Evaluation the motor dysfunction 6months after intrathecal injection. | 6months | 
| sensory dysfunction | Evaluation the sensory dysfunction after intrathecal injection of CD133 cells. | 6months | 
| unconsciousness | Evaluation the rate of unconsciousness during 48hours after cell transplantation. | 48hours | 
| fever | Evaluation the symptom of infection like fever 48hours after cell transplantation. | 48hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motor improvement | Measure the improvement of motor system by GMFM66. | 6months | 
| Balance improvement | Measure the balance improvement by BBS. | 6months | 
| Spasm | Evaluation the improvement of spasm after stem cell transplantation. | 6months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy CD133 cells intrathecal injection