Clinical Trial: Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy

Brief Summary:

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.


Detailed Summary: 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
Sponsor: Royan Institute

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Royan Institute

Dates:
Date Received: December 25, 2012
Date Started: April 2012
Date Completion:
Last Updated: April 24, 2014
Last Verified: January 2011