Trial record 7 of 265 for:    Open Studies | "Paralysis"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by General Hospital of Chinese Armed Police Forces
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01929434
First received: August 20, 2013
Last updated: August 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Cerebral Palsy
Other: rehabilitation
Procedure: stem cell injection
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by General Hospital of Chinese Armed Police Forces:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Routine Blood Test and Biochemical Test [ Time Frame: Change from baseline at 12 monthes after enrollment or transplantation ] [ Designated as safety issue: Yes ]
    1. red blood cell
    2. white blood cell
    3. platelet count
    4. glutamic pyruvic transaminase
    5. glutamic oxaloacetic transaminase


Other Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: rehabilitation
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.

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

Ages Eligible for Study:   1 Year to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929434

Contacts
Contact: Yihua An, Doctor 0086-10-57976848 doctoran2010@hotmail.com

Locations
China, Beijing
General Hospital of Chinese People's Armed Police Forces
Beijing, Beijing, China, 100050
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
Study Director: Yihua An, Doctor the General Hospital of Chinese People's Armed Police Forces
  More Information

Publications:
Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01929434     History of Changes
Other Study ID Numbers: 2013-05-13 CP III
Study First Received: August 20, 2013
Last Updated: August 21, 2013
Health Authority: China: Ethics Committee

Keywords provided by General Hospital of Chinese Armed Police Forces:
cerebral palsy
cell transplantation
rehabilitation

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014