Back to resultsOutcomes of Stem Cells for Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Autologous Bone Marrow Mononuclear Cells
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Stem Cells
Eligibility 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
Sites / Locations
- Vinmec International Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stem cell transplantation
Arm Description
2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
Outcomes
Primary Outcome Measures
Change in Total Score of Gross Motor Function Measure (GMFM)-88
GMFM-88
Change in Gross Motor Function Measure (GMFM)-66 Percentile
GMFM-66 percentile
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: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy
Change in Denver Developmental Score
Denver II
Change in Quality of Life
Quality of life questionnaire for cerebral palsy (CPQOL)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02574923
Brief Title
Outcomes of Stem Cells for Cerebral Palsy
Official Title
Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 5, 2015 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 30 patients with cerebral palsy 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
Cerebral Palsy
Keywords
Cerebral Palsy, Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stem cell transplantation
Arm Type
Experimental
Arm Description
2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
Intervention Type
Biological
Intervention Name(s)
Autologous Bone Marrow Mononuclear Cells
Intervention Description
Transplantation of Autologous Bone Marrow Mononuclear Cells
Primary Outcome Measure Information:
Title
Change in Total Score of Gross Motor Function Measure (GMFM)-88
Description
GMFM-88
Time Frame
3 months and 6 months after transplantation
Title
Change in Gross Motor Function Measure (GMFM)-66 Percentile
Description
GMFM-66 percentile
Time Frame
3 months and 6 months after transplantation
Secondary Outcome Measure Information:
Title
Change in Muscle tone
Description
Muscle tone are assessed by Modified Ashworth Scale
Time Frame
3 months and 6 months after transplantation
Title
Number of adverse events
Description
Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy
Time Frame
Through study completion, an average of 6 months
Title
Change in Denver Developmental Score
Description
Denver II
Time Frame
3 months and 6 months after transplantation
Title
Change in Quality of Life
Description
Quality of life questionnaire for cerebral palsy (CPQOL)
Time Frame
3 months and 6 months after transplantation
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen, MD., PhD.
Organizational Affiliation
Vinmec Healthcare System
Official's Role
Study Chair
Facility Information:
Facility Name
Vinmec International Hospital
City
Hanoi
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
25788947
Citation
Sharma A, Sane H, Gokulchandran N, Kulkarni P, Gandhi S, Sundaram J, Paranjape A, Shetty A, Bhagwanani K, Biju H, Badhe P. A clinical study of autologous bone marrow mononuclear cells for cerebral palsy patients: a new frontier. Stem Cells Int. 2015;2015:905874. doi: 10.1155/2015/905874. Epub 2015 Feb 18.
Results Reference
background
PubMed Identifier
30107811
Citation
Nguyen TL, Nguyen HP, Nguyen TK. The effects of bone marrow mononuclear cell transplantation on the quality of life of children with cerebral palsy. Health Qual Life Outcomes. 2018 Aug 14;16(1):164. doi: 10.1186/s12955-018-0992-x.
Results Reference
derived
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Outcomes of Stem Cells for Cerebral Palsy
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