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Neural Stem Cells Therapy for Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03005249
Recruitment Status : Unknown
Verified February 2018 by Liu Jing, The First Affiliated Hospital of Dalian Medical University.
Recruitment status was:  Recruiting
First Posted : December 29, 2016
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Liu Jing, The First Affiliated Hospital of Dalian Medical University

Study Description
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Brief Summary:
To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Procedure: neural stem cells therapy group Other: the control group Not Applicable

Detailed Description:
Cerebral palsy is the most severe lifelong disability disease in childhood. In China, an epidemiological investigation of cerebral palsy in 2004 has reported that 2.74‰ (about 6.50-9.75 million) of children suffered from cerebral palsy. The costs of medical expenses, living allowance and nursing care can go up to RMB 20000-50000 yuan per year for each child with cerebral palsy and thus China will expend RMB 120-300 billion yuan per year for children with cerebral palsy. With full liberalization of two-child policy, there is an increasing number of second babies born to women who are 35 years or older. Thus, the incidence of cerebral palsy tends to increase. There is currently no cure for cerebral palsy, resulting in a heavy burden for families and on society. Recent clinical trials performed in countries outside China have demonstrated that stem cell therapy is likely the most effective method to treat cerebral palsy. Fifteen trials regarding stem cell therapy for cerebral palsy have been registered with ClinicalTrials.gov. In China, there have been no standardized registered trials regarding stem cell therapy for cerebral palsy, which greatly restricts its clinical application. In October 2016, the National Health and Family Planning Commission and the Food and Drug Administration of China jointly announced the premier stem cell clinical research institutions, making performing standardized trials regarding stem cell therapy for cerebral palsy in China possible.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Neural Stem Cells Therapy for Cerebral Palsy: a Prospective, Randomized, Parallel-controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: neural stem cells therapy group
The patients will be assigned to neural stem cells therapy group for cerebral palsy.
 Procedure: neural stem cells therapy group
The patients will be assigned to neural stem cells therapy group for cerebral palsy.
Experimental: the control group
The patients will be assigned to the control group for cerebral palsy.
 Other: the control group
The patients will be assigned to the control group for cerebral palsy.


Outcome Measures
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Primary Outcome Measures :
  1. GMFM-88 score [ Time Frame: changes of month 1, month 3, month 6, month 9 and month 12 after therapy ]
    To evaluate change in gross motor function in children with cerebral palsy.


Secondary Outcome Measures :
  1. Fine Motor Function Measure (FMFM) score [ Time Frame: changes of month 1, month 3, month 6, month 9 and month 12 after therapy ]
    To evaluate change in fine motor function in children with cerebral palsy.

  2. Modified Ashworth Scale score [ Time Frame: changes of month 1, month 3, month 6, month 9 and month 12 after therapy ]
    To measure resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates with ischemic/hypoxic cerebral palsy (mainly including neonate with asphyxia and premature infants);
  • Clinical manifestation of spastic tetraplegia;
  • With moderate to severe cerebral palsy, The Gross Motor Function; Classification System (GMFCS) levels IV-V;
  • Age 1-5 years, of either sex;
  • Provision of signed informed consent by one of his/her parents or legal guardians prior to commencement of this study;

Exclusion Criteria:

  • Systemic diseases that possibly influence treatment or patient's compliance;
  • Potentially life-threatening diseases involving various organ systems;
  • Brain deformity;
  • Abnormal behaviors or mood disorder;
  • Allergies from blood products;
  • Suffering from infectious disease;
  • Subjected to craniocerebral operations prior to screening.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005249


Contacts
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Contact: Jing Liu, Ph.D 86041184394568 liujing.dlrmc@hotmail.com

Locations
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China, Liaoning
The First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116011
Contact: Jing Liu, Ph.D    86041184394568    liujing.dlrmc@hotmail.com   
Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
Investigators
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Principal Investigator: Jing Liu, Ph.D The First Affiliated Hospital of Dalian Medical University
More Information
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Responsible Party: Liu Jing, Chief Physician, The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT03005249    
Other Study ID Numbers: LCKY2016-60
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases