Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy
Recruitment status was Recruiting
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.
Biological: stem cell intrathecal injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]Evaluation the motor dysfunction 6months after intrathecal injection.
- sensory dysfunction [ Time Frame: 6months ] [ Designated as safety issue: Yes ]Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.
- unconsciousness [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]Evaluation the rate of unconsciousness during 48hours after cell transplantation.
- fever [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]Evaluation the symptom of infection like fever 48hours after cell transplantation.
- motor improvement [ Time Frame: 6months ] [ Designated as safety issue: No ]Measure the improvement of motor system by GMFM66.
- Balance improvement [ Time Frame: 6months ] [ Designated as safety issue: No ]Measure the balance improvement by BBS.
- Spasm [ Time Frame: 6months ] [ Designated as safety issue: No ]Evaluation the improvement of spasm after stem cell transplantation.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated 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.
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
|Contact: Nasser Aghdami, MD,PhD||+9821235622000 ext firstname.lastname@example.org|
|Contact: Leila Arab, MD||+982123562000 ext email@example.com|
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Contact: Nasser Aghdami, MD,PhD +982123562000 ext 504 firstname.lastname@example.org|
|Contact: Leila Arab, MD +982123562000 ext 414 email@example.com|
|Principal Investigator: Leila Arab, MD|
|Principal Investigator: Farzad Ashraafi, MD|
|Sub-Investigator: Soura Mardpour, MSc|
|Sub-Investigator: Vagihe Azimian, PhD student|
|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|