Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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:

Related Info 

• Responsible Party: Royan Institute
• ClinicalTrials.gov Identifier: NCT01763255
• Other Study ID Numbers: Royan-Nerve-003
• First Posted: January 8, 2013
• 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:

Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases