Cerebral Palsy
Conditions
Keywords
cerebral palsy, cell transplantation, rehabilitation
Brief summary
Cerebral palsy (CP) is described as a group of permanent disorders affecting motor development and posture, resulting in activity limitation attributed to nonprogressive disturbances of the fetal or infant brain. The prevalence of cerebral palsy has increased among the children with low birth-weight, jaundice, respiratory distress and intrauterine infection and so on. The incidence of cerebral palsy is increasing gradually with increased neonatal survival rate. Although there are many kinds of functional therapy programs especially the rehabilitation treatment for cerebral palsy, their effects are limited. Increasing cerebral palsy patients become a heavy burden to the family and society. Stem cell based therapy, a new prospective therapy for central nervous system disorders, has the potential to repair the damaged brain tissue in patients with cerebral palsy. In this study, 300 patients with cerebral palsy will be divided into three groups and the investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 CP patients of them randomly. We will also follow up the other 100 patients who only receive rehabilitation treatment and another 100 patients who accept neither stem cell therapy nor rehabilitation treatment. On this basis, as the investigators we can compare the efficacy of cell therapy and rehabilitation treatments for cerebral palsy patients. Multiple sources of assessment were used to ascertain and classify all cases of cerebral palsy. Particularly the Gross Motor Function Measure (GMFM) as an important valid and reliable outcome measure, has made it possible to evaluate the severity of movement disability，change over time and the effects of clinical interventions. It also will be the primary outcome measure in follow-up analysis of this study.
Detailed description
Patients enrolled in this study need to finish our whole follow-up survey for 12 months, which is carried out by clinical doctors, rehabilitators and epidemiologist.
Interventions
OTHERrehabilitation
Patients only receive rehabilitation of physical therapy and occupational therapy.
BIOLOGICALstem cell injection
Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.
Sponsors
General Hospital of Chinese Armed Police Forces
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Patients with diagnosis of cerebral palsy. * Patients' curator must be able to give voluntary consent.
Exclusion criteria
* Intracranial infection. * Severe respiratory and circulatory system diseases. * Hematologic malignancies. * Positive serological tests such as AIDS, hepatitis B virus, hepatitis C virus and syphilis （antigen or antibody）. * Tumors. * Genetic and metabolic diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure Score | Change from baseline at 12 monthes after enrollment or transplantation | Gross Motor Function Measure-88 and Gross Motor Function Measure-66 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Routine Blood Test and Biochemical Test | Change from baseline at 12 monthes after enrollment or transplantation | 1. red blood cell 2. white blood cell 3. platelet count 4. glutamic pyruvic transaminase 5. glutamic oxaloacetic transaminase |
Other
| Measure | Time frame | Description |
|---|---|---|
| Magnetic resonance imaging （MRI） | Change from baseline at 12 monthes after enrollment or transplantation | The MRI repots would describe brain tissue especially white matter and malacia. |
Countries
China
Outcome results
None listed