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Side Effects of Bone Marrow Derived CD133 Transplantation 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. Identifier: NCT01404663
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : March 7, 2018
Information provided by (Responsible Party):
Royan Institute

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 bone marrow stem cell transplantation in patients with cerebral palsy.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Biological: CD133 stem cell injection Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation the Side Effects of Bone Marrow Derived CD133 Cells Transplantation in Cerebral Palsy Patients
Study Start Date : October 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. allergic reaction [ Time Frame: 1 month ]
    evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients

  2. local infection [ Time Frame: 1 month ]
    infections in site of injection

  3. encephalitis [ Time Frame: 1 month ]
    encephalitis due to cell transplantation

  4. meningitis [ Time Frame: 1 month ]
    meningitis due to cell trnsplantation

  5. paralysis or sensory loss [ Time Frame: 6 months ]
    paralysis or sensory loss below the level of the injection site

Secondary Outcome Measures :
  1. speech [ Time Frame: 6 months ]
    evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy

  2. motion [ Time Frame: 6 months ]
    evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia)
  2. 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.
  3. Children who have a metallic or electrical implants

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 identifier (NCT number): NCT01404663

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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
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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
Principal Investigator: Leila Arab, MD Department of regenerative medicine,Royan Institute

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Royan Institute Identifier: NCT01404663    
Other Study ID Numbers: Royan-nerve-002
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: August 2010
Keywords provided by Royan Institute:
bone marrow CD133 transplantation side effects
side effects
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases