Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Patients With Cerebral Paralysis

Cerebral Palsy Clinical Trial

— CP  

Official title:

Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Children With Cerebral Paralysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929434
• Other study ID #: 2013-05-13 CP III
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2013
• Last updated: December 23, 2017
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: General Hospital of Chinese Armed Police Forces
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• rehabilitation
Patients only receive rehabilitation of physical therapy and occupational therapy.

Biological:
• stem cell injection
Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.

Locations

Country	Name	City	State
China	General Hospital of Chinese People's Armed Police Forces	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

References & Publications (6)

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

Outcome

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