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Outcomes of Stem Cells for Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02574923
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Vinmec Healthcare System

Study Description
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Brief Summary:
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Biological: Autologous Bone Marrow Mononuclear Cells Phase 2

Detailed Description:
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 30 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
Actual Study Start Date : November 5, 2015
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem cell transplantation
2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
 Biological: Autologous Bone Marrow Mononuclear Cells
Transplantation of Autologous Bone Marrow Mononuclear Cells


Outcome Measures
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Primary Outcome Measures :
  1. Change in Total Score of Gross Motor Function Measure (GMFM)-88 [ Time Frame: 3 months and 6 months after transplantation ]
    GMFM-88

  2. Change in Gross Motor Function Measure (GMFM)-66 Percentile [ Time Frame: 3 months and 6 months after transplantation ]
    GMFM-66 percentile


Secondary Outcome Measures :
  1. Change in Muscle tone [ Time Frame: 3 months 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: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy

  3. Change in Denver Developmental Score [ Time Frame: 3 months and 6 months after transplantation ]
    Denver II

  4. Change in Quality of Life [ Time Frame: 3 months and 6 months after transplantation ]
    Quality of life questionnaire for cerebral palsy (CPQOL)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cerebral palsy of any types caused by oxygen deprivation.

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): NCT02574923


Locations
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Vietnam
Vinmec International Hospital
Hanoi, Vietnam
Sponsors and Collaborators
Vinmec Healthcare System
Investigators
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Study Chair: Liem T Nguyen, MD., PhD. Vinmec Healthcare System
More Information
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Publications:

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

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Responsible Party: Vinmec Healthcare System
ClinicalTrials.gov Identifier: NCT02574923    
Other Study ID Numbers: TBG 002
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Keywords provided by Vinmec Healthcare System:
Cerebral Palsy
Stem Cells
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
 Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases