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Outcomes of Stem Cells for Cerebral Palsy

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: NCT02569775
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Vinmec Healthcare System

Tracking Information
First Submitted Date  ICMJE October 2, 2015
First Posted Date  ICMJE October 7, 2015
Last Update Posted Date October 16, 2015
Study Start Date  ICMJE April 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2015)
  • Change in Total Score of Gross Motor Function Measure (GMFM)-88 [ Time Frame: 3 months and 6 months after transplantation ]
    GMFM-88
  • Change in Gross Motor Function Measure (GMFM)-66 Percentile [ Time Frame: 3 months and 6 months after transplantation ]
    GMFM-66 percentile
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02569775 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2015)
  • Change in Muscle tone [ Time Frame: 3 months and 6 months after transplantation ]
    Muscle tone are assessed by Modified Ashworth Scale
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcomes of Stem Cells for Cerebral Palsy
Official Title  ICMJE Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
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.
Detailed Description The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE Biological: Autologous Bone Marrow Mononuclear Cells
Transplantation of Autologous Bone Marrow Mononuclear Cells
Study Arms  ICMJE Experimental: Stem cell transplantation
2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
Intervention: Biological: Autologous Bone Marrow Mononuclear Cells
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: October 7, 2015)
40
Original Actual Enrollment  ICMJE
 (submitted: October 6, 2015)
45
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02569775
Other Study ID Numbers  ICMJE TBG 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vinmec Healthcare System
Study Sponsor  ICMJE Vinmec Healthcare System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Liem T Nguyen, MD., PhD. Vinmec Healthcare System
PRS Account Vinmec Healthcare System
Verification Date October 2015

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