Cerebral Palsy Clinical Trial
— CPOfficial title:
Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Children With Cerebral Paralysis
Verified date | July 2015 |
Source | General Hospital of Chinese Armed Police Forces |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 14 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | General Hospital of Chinese People's Armed Police Forces | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
General Hospital of Chinese Armed Police Forces |
China,
Himmelmann K. Epidemiology of cerebral palsy. Handb Clin Neurol. 2013;111:163-7. doi: 10.1016/B978-0-444-52891-9.00015-4. Review. — View Citation
Lubis MU, Tjipta GD, Marbun MD, Saing B. Cerebral palsy. Paediatr Indones. 1990 Mar-Apr;30(3-4):65-70. — View Citation
Pharoah PO, Platt MJ, Cooke T. The changing epidemiology of cerebral palsy. Arch Dis Child Fetal Neonatal Ed. 1996 Nov;75(3):F169-73. — View Citation
Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. Review. — View Citation
Rethlefsen SA, Ryan DD, Kay RM. Classification systems in cerebral palsy. Orthop Clin North Am. 2010 Oct;41(4):457-67. doi: 10.1016/j.ocl.2010.06.005. Review. — View Citation
Richards CL, Malouin F. Cerebral palsy: definition, assessment and rehabilitation. Handb Clin Neurol. 2013;111:183-95. doi: 10.1016/B978-0-444-52891-9.00018-X. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Magnetic resonance imaging (MRI) | The MRI repots would describe brain tissue especially white matter and malacia. | Change from baseline at 12 monthes after enrollment or transplantation | |
Primary | Gross Motor Function Measure Score | Gross Motor Function Measure-88 and Gross Motor Function Measure-66 | Change from baseline at 12 monthes after enrollment or transplantation | |
Secondary | Routine Blood Test and Biochemical Test | red blood cell white blood cell platelet count glutamic pyruvic transaminase glutamic oxaloacetic transaminase |
Change from baseline at 12 monthes after enrollment or transplantation |
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