Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy
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.
|Cerebral Palsy||Biological: stem cell intrathecal injection||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy|
- motor dysfunction [ Time Frame: 6months ]Evaluation the motor dysfunction 6months after intrathecal injection.
- sensory dysfunction [ Time Frame: 6months ]Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.
- unconsciousness [ Time Frame: 48hours ]Evaluation the rate of unconsciousness during 48hours after cell transplantation.
- fever [ Time Frame: 48hours ]Evaluation the symptom of infection like fever 48hours after cell transplantation.
- motor improvement [ Time Frame: 6months ]Measure the improvement of motor system by GMFM66.
- Balance improvement [ Time Frame: 6months ]Measure the balance improvement by BBS.
- Spasm [ Time Frame: 6months ]Evaluation the improvement of spasm after stem cell transplantation.
|Study Start Date:||April 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: CD133 transplantation
The patients with cerebral palsy that underwent CD133 transplantation.
Biological: stem cell intrathecal injection
Intrathecal injection of Bone marrow derived CD133 cells
Other Name: Stem cell transplantation
No Intervention: Control
The patients with cerebral palsy that underwent regular observation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763255
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||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|