Clinical trial NCT01763255: Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy
Official title: The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cerebral Palsy
Keywords: cerebral palsy CD133 cells intrathecal injection
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2013-01-08
Enrollment: 8
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: motor dysfunction
timeFrame: 6months
measure: sensory dysfunction
timeFrame: 6months
measure: unconsciousness
timeFrame: 48hours
measure: fever
timeFrame: 48hours
Secondary outcomes:
measure: motor improvement
timeFrame: 6months
measure: Balance improvement
timeFrame: 6months
measure: Spasm
timeFrame: 6months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Royan department of degenerative medicine,Head of Royan celltherapy center
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Head of Neurosurgery research center of Shahid Beheshti University
name: Ali Reza Zali, MD
role: STUDY_DIRECTOR
References: