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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Biological: stem cell intrathecal injection

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Stem cell transplantation
No Intervention: Control; The patients with cerebral palsy that underwent regular observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
motor dysfunction	Evaluation the motor dysfunction 6months after intrathecal injection.	6months
sensory dysfunction	Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.	6months
unconsciousness	Evaluation the rate of unconsciousness during 48hours after cell transplantation.	48hours
fever	Evaluation the symptom of infection like fever 48hours after cell transplantation.	48hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
motor improvement	Measure the improvement of motor system by GMFM66.	6months
Balance improvement	Measure the balance improvement by BBS.	6months
Spasm	Evaluation the improvement of spasm after stem cell transplantation.	6months

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 25, 2012
• First Submitted That Met QC Criteria: January 5, 2013
• First Posted (Estimate): January 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 25, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: cerebral palsy CD133 cells intrathecal injection
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: Royan-Nerve-003