Royan Institute
Tehran, Iran
NCT Number: NCT01763255
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.
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Notify Me4 year–12 year
All sexes
Interventional
Phase 1 / Phase 2
Tehran, Iran
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children who have a metallic or electrical implants
Intrathecal injection of Bone marrow derived CD133 cells
Other names: Stem cell transplantation
Time frame: 6months
Evaluation the motor dysfunction 6months after intrathecal injection.
Time frame: 6months
Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.
Time frame: 48hours
Evaluation the rate of unconsciousness during 48hours after cell transplantation.
Time frame: 48hours
Evaluation the symptom of infection like fever 48hours after cell transplantation.
Time frame: 6months
Measure the improvement of motor system by GMFM66.
Time frame: 6months
Measure the balance improvement by BBS.
Time frame: 6months
Evaluation the improvement of spasm after stem cell transplantation.
Royan Institute
Other Gov
The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy
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