Cerebral Palsy Clinical Trial
Official title:
Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Children With Cerebral Paralysis
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.
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. ;
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