Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01763255
First received: December 25, 2012
Last updated: April 24, 2014
Last verified: January 2011
  Purpose

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 Intervention Phase
Cerebral Palsy
Biological: stem cell intrathecal injection
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 8
Study Start Date: April 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763255

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01763255     History of Changes
Other Study ID Numbers: Royan-Nerve-003
Study First Received: December 25, 2012
Last Updated: April 24, 2014
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
cerebral palsy CD133 cells intrathecal injection

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014