Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

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.
 
ClinicalTrials.gov Identifier: NCT01763255
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Biological: stem cell intrathecal injection Phase 1 Phase 2

Detailed Description:
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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : April 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. motor dysfunction [ Time Frame: 6months ]
    Evaluation the motor dysfunction 6months after intrathecal injection.

  2. sensory dysfunction [ Time Frame: 6months ]
    Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.

  3. unconsciousness [ Time Frame: 48hours ]
    Evaluation the rate of unconsciousness during 48hours after cell transplantation.

  4. fever [ Time Frame: 48hours ]
    Evaluation the symptom of infection like fever 48hours after cell transplantation.


Secondary Outcome Measures :
  1. motor improvement [ Time Frame: 6months ]
    Measure the improvement of motor system by GMFM66.

  2. Balance improvement [ Time Frame: 6months ]
    Measure the balance improvement by BBS.

  3. Spasm [ Time Frame: 6months ]
    Evaluation the improvement of spasm after stem cell transplantation.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763255


Locations
Layout table for location information
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01763255    
Other Study ID Numbers: Royan-Nerve-003
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: January 2011
Keywords provided by Royan Institute:
cerebral palsy CD133 cells intrathecal injection
Additional relevant MeSH terms:
Layout table for MeSH terms
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
 Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases