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

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ClinicalTrials.gov Identifier: NCT01929434
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces

Tracking Information
First Submitted Date  ICMJE August 20, 2013
First Posted Date  ICMJE August 28, 2013
Last Update Posted Date December 27, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
Gross Motor Function Measure Score [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ]
Gross Motor Function Measure-88 and Gross Motor Function Measure-66
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01929434 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
Routine Blood Test and Biochemical Test [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ]
  1. red blood cell
  2. white blood cell
  3. platelet count
  4. glutamic pyruvic transaminase
  5. glutamic oxaloacetic transaminase
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 21, 2013)
Magnetic resonance imaging (MRI) [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ]
The MRI repots would describe brain tissue especially white matter and malacia.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Patients With Cerebral Paralysis
Official Title  ICMJE Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Children With Cerebral Paralysis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • Other: rehabilitation
    Patients only receive rehabilitation of physical therapy and occupational therapy.
    Other Name: phsical exercise rehabilitation
  • Biological: stem cell injection
    Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.
Study Arms  ICMJE
  • 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.
    Intervention: Other: 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.
    Intervention: Biological: stem cell injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2013)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01929434
Other Study ID Numbers  ICMJE 2013-05-13 CP III
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party General Hospital of Chinese Armed Police Forces
Study Sponsor  ICMJE General Hospital of Chinese Armed Police Forces
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yihua An, Doctor the General Hospital of Chinese People's Armed Police Forces
PRS Account General Hospital of Chinese Armed Police Forces
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP