Clinical trial NCT01929434: Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Patients With Cerebral Paralysis
Official title: Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Children With Cerebral Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Palsy
Keywords: cerebral palsy
cell transplantation
rehabilitation
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gross Motor Function Measure Score
timeFrame: Change from baseline at 12 monthes after enrollment or transplantation
Secondary outcomes:
measure: Routine Blood Test and Biochemical Test
timeFrame: Change from baseline at 12 monthes after enrollment or transplantation
Other outcomes:
measure: Magnetic resonance imaging （MRI）
timeFrame: Change from baseline at 12 monthes after enrollment or transplantation
Locations:
city: Beijing
country: China
facility: General Hospital of Chinese People's Armed Police Forces
state: Beijing
Study officials:
affiliation: the General Hospital of Chinese People's Armed Police Forces
name: Yihua An, Doctor
role: STUDY_DIRECTOR
References:
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