Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Patients With Cerebral Paralysis (CP)
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.
Procedure: stem cell injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Children With Cerebral Paralysis|
- Gross Motor Function Measure Score [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ] [ Designated as safety issue: Yes ]Gross Motor Function Measure-88 and Gross Motor Function Measure-66
- Routine Blood Test and Biochemical Test [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ] [ Designated as safety issue: Yes ]
- red blood cell
- white blood cell
- platelet count
- glutamic pyruvic transaminase
- glutamic oxaloacetic transaminase
- Magnetic resonance imaging （MRI） [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ] [ Designated as safety issue: Yes ]The MRI repots would describe brain tissue especially white matter and malacia.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: rehabilitation
Patients in the group accept rehabilitation for three weeks in hospital and other eleven months in their home under the guidance of physical therapist.
Patients only receive rehabilitation of physical therapy and occupational therapy.
Other Name: phsical exercise rehabilitation
No Intervention: control
Patients receive no professional treatment in hospital or rehabilitation centre.
Experimental: stem cell injection
Patients in the group accept cell therapy including four times stem cells transplant via intrathecal injection.
Procedure: stem cell injection
Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01929434
|Contact: Yihua An, Doctorfirstname.lastname@example.org|
|General Hospital of Chinese People's Armed Police Forces||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Yihua An, Ph D 0086-10-57976848 email@example.com|
|Contact: Rongrong Hua 0086-10-57976866 firstname.lastname@example.org|
|Principal Investigator: Yihua An, Ph D|
|Study Director:||Yihua An, Doctor||the General Hospital of Chinese People's Armed Police Forces|