Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis
Primary Purpose
Encephalitis, Meningitis
Status
Completed
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
Stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Encephalitis focused on measuring encephalitis, meningitis, neurological sequelae due
Eligibility Criteria
Inclusion Criteria:
- Neurological sequelae due to encephalitis or meningitis
Exclusion Criteria:
- Coagulation disorders
- Allergy to anesthetic agents
- Severe health conditions such as cancer, failure of heart, lung, liver or kidney
- Active infections
Sites / Locations
- Vinmec Research Institute of Stem Cell and Gene Technology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stem cell transplantation
Arm Description
Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
Outcomes
Primary Outcome Measures
GMFM-88
Change in Total Score of Gross Motor Function Measure GMFM-88
Secondary Outcome Measures
Change in Muscle tone
Muscle tone are assessed by Modified Ashworth Scale
Number of adverse events
Examples of adverse events to look for: fever, infections, vomit, epilepsy
Full Information
NCT ID
NCT04080921
First Posted
September 4, 2019
Last Updated
September 4, 2019
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
1. Study Identification
Unique Protocol Identification Number
NCT04080921
Brief Title
Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis
Official Title
The Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis at Vinmec International Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 16, 2014 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in-patient with neurological sequelae due to encephalitis or meningitis
Detailed Description
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mononuclear cell in 22 patients with neurological sequelae due to encephalitis or meningitis at Vinmec International Hospital, Hanoi, Vietnam
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Meningitis
Keywords
encephalitis, meningitis, neurological sequelae due
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stem cell transplantation
Arm Type
Experimental
Arm Description
Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
Intervention Type
Combination Product
Intervention Name(s)
Stem cell transplantation
Intervention Description
Transplantation of Autologous Bone Marrow Mononuclear Cells
Primary Outcome Measure Information:
Title
GMFM-88
Description
Change in Total Score of Gross Motor Function Measure GMFM-88
Time Frame
Baseline, 6 months, and 12 months after transplantation
Secondary Outcome Measure Information:
Title
Change in Muscle tone
Description
Muscle tone are assessed by Modified Ashworth Scale
Time Frame
Baseline, 6 months, and 12 months after transplantation
Title
Number of adverse events
Description
Examples of adverse events to look for: fever, infections, vomit, epilepsy
Time Frame
Through study completion, an average of 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neurological sequelae due to encephalitis or meningitis
Exclusion Criteria:
Coagulation disorders
Allergy to anesthetic agents
Severe health conditions such as cancer, failure of heart, lung, liver or kidney
Active infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen
Organizational Affiliation
Vinmec Research Institute of Stem Cell and Gene Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28296863
Citation
Bansal H, Singh L, Verma P, Agrawal A, Leon J, Sundell IB, Koka PS. Administration of Autologous Bone Marrow-Derived Stem Cells for Treatment of Cerebral Palsy Patients: A Proof of Concept. J Stem Cells. 2016;11(1):37-49.
Results Reference
result
PubMed Identifier
28403842
Citation
Nguyen LT, Nguyen AT, Vu CD, Ngo DV, Bui AV. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial. BMC Pediatr. 2017 Apr 12;17(1):104. doi: 10.1186/s12887-017-0859-z.
Results Reference
result
Learn more about this trial
Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis
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