The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Transplantation of Autologous Bone Marrow Mononuclear Cells
Vinmec International Hospital
Hanoi, Vietnam
Change in Total Score of Gross Motor Function Measure (GMFM)-88
GMFM-88
Time frame: 3 months and 6 months after transplantation
Change in Gross Motor Function Measure (GMFM)-66 Percentile
GMFM-66 percentile
Time frame: 3 months and 6 months after transplantation
Change in Muscle tone
Muscle tone are assessed by Modified Ashworth Scale
Time frame: 3 months and 6 months after transplantation
Number of adverse events
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
Change in Denver Developmental Score
Denver II
Time frame: 3 months and 6 months after transplantation
Change in Quality of Life
Quality of life questionnaire for cerebral palsy (CPQOL)
Time frame: 3 months and 6 months after transplantation
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