Cerebral Palsy
Conditions
Keywords
bone marrow CD133 transplantation side effects, side effects
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.
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.
Interventions
BIOLOGICALCD133 stem cell injection
Bone marrow derived CD133 stem cell witch are transplanted by intrathecal injection
Sponsors
Royan Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local infection | 1 month | infections in site of injection |
| meningitis | 1 month | meningitis due to cell trnsplantation |
| paralysis or sensory loss | 6 months | paralysis or sensory loss below the level of the injection site |
| allergic reaction | 1 month | evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients |
| encephalitis | 1 month | encephalitis due to cell transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| motion | 6 months | evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy |
| speech | 6 months | evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy |
Countries
Iran
Outcome results
None listed