Side Effects of Bone Marrow Derived CD133 Transplantation 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 bone marrow stem cell transplantation in patients with cerebral palsy.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation the Side Effects of Bone Marrow Derived CD133 Cells Transplantation in Cerebral Palsy Patients|
- allergic reaction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients
- local infection [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]infections in site of injection
- encephalitis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]encephalitis due to cell transplantation
- meningitis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]meningitis due to cell trnsplantation
- paralysis or sensory loss [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]paralysis or sensory loss below the level of the injection site
- speech [ Time Frame: 6 months ] [ Designated as safety issue: No ]evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy
- motion [ Time Frame: 6 months ] [ Designated as safety issue: No ]evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy
|Study Start Date:||October 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: stem cell recipients
The 4-12 years old patients with cerebral palsy who undergone bone marrow derived CD133 transplantation
Biological: CD133 stem cell injection
Bone marrow derived CD133 stem cell witch are transplanted by intrathecal injection
Other Name: stem cell transplantation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404663
|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 Cell therapy Center|
|Principal Investigator:||AliReza Zaali, MD||Head of Research center of neurosurgery|