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Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123562
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus

Condition or disease Intervention/treatment Phase
Cerebral Palsy Combination Product: Stem cell transplantation Phase 2

Detailed Description:
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus at Vinmec International Hospital, Hanoi, Vietnam
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus: An Open-label, Uncontrolled Clinical Trial
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : October 31, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem cell transplantation
Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
 Combination Product: Stem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear Cells


Outcome Measures
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Primary Outcome Measures :
  1. GMFM-88 and GMFM-66 Percentile [ Time Frame: Time Frame: Baseline and 6 months after transplantation ]
    Change in Total Score of Gross Motor Function Measure GMFM-88 and GMFM-66 Percentile


Secondary Outcome Measures :
  1. Change in Muscle tone [ Time Frame: Time Frame: Baseline and 6 months after transplantation ]
    Muscle tone are assessed by Modified Ashworth Scale

  2. Number of adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Examples of adverse events to look for: fever, infections, vomit, epilepsy


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cerebral palsy of any types caused by neonatal icterus

Exclusion Criteria:

  • Epilepsy
  • Hydrocephalus with ventricular drain
  • Coagulation disorders
  • Allergy to anesthetic agents
  • Severe health conditions such as cancer, failure of heart, lung, liver or kidney
  • Active infections
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): NCT03123562


Locations
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Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 100000
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology
Investigators
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Principal Investigator: Liem T Nguyen, MD., PhD Vinmec Research Institute of Stem Cell and Gene Technology
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT03123562    
Other Study ID Numbers: VinmecRISCGT68
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vinmec Research Institute of Stem Cell and Gene Technology:
Cerebral palsy
Stem cells
Neonatal icterus
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Jaundice
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
 Brain Diseases
Central Nervous System Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations