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Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763255
First Posted: January 8, 2013
Last Update Posted: April 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royan Institute
December 25, 2012
January 8, 2013
April 25, 2014
April 2012
April 2014   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01763255 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy
The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With 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.

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
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cerebral Palsy
Biological: stem cell intrathecal injection
Intrathecal injection of Bone marrow derived CD133 cells
Other Name: Stem cell transplantation
  • Experimental: CD133 transplantation
    The patients with cerebral palsy that underwent CD133 transplantation.
    Intervention: Biological: stem cell intrathecal injection
  • No Intervention: Control
    The patients with cerebral palsy that underwent regular observation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of spastic quadriplegic CP Children must be between the ages of 4 and 12 years Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees) Children must be seizure-free or seizure controlled

Exclusion Criteria:

  • Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia) Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.

Children who have a metallic or electrical implants

Sexes Eligible for Study: All
4 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01763255
Royan-Nerve-003
Yes
Not Provided
Not Provided
Royan Institute
Royan Institute
Not Provided
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
Royan Institute
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP