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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD133 transplantation | Experimental | The patients with cerebral palsy that underwent CD133 transplantation. |
|
| Control | No Intervention | The patients with cerebral palsy that underwent regular observation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stem cell intrathecal injection | Biological | Intrathecal injection of Bone marrow derived CD133 cells |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| motor improvement | Measure the improvement of motor system by GMFM66. | 6months |
| Balance improvement | Measure the balance improvement by BBS. |
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Inclusion Criteria:
Exclusion Criteria:
Children who have a metallic or electrical implants
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Nasser Aghdami, MD,PhD | Head of Royan department of degenerative medicine,Head of Royan celltherapy center | Study Director |
| Ali Reza Zali, MD | Head of Neurosurgery research center of Shahid Beheshti University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Tehran | Iran |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 6months |
| Spasm | Evaluation the improvement of spasm after stem cell transplantation. | 6months |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |