Cerebral Palsy
Conditions
Keywords
Cerebral palsy, Stem cells, Neonatal icterus
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus
Detailed description
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus at Vinmec International Hospital, Hanoi, Vietnam
Interventions
COMBINATION_PRODUCTStem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear Cells
Sponsors
Vinmec Research Institute of Stem Cell and Gene Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Cerebral palsy of any types caused by neonatal icterus
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMFM-88 and GMFM-66 Percentile | Time Frame: Baseline and 6 months after transplantation | Change in Total Score of Gross Motor Function Measure GMFM-88 and GMFM-66 Percentile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle tone | Time Frame: Baseline and 6 months after transplantation | Muscle tone are assessed by Modified Ashworth Scale |
| Number of adverse events | Through study completion, an average of 6 months | Examples of adverse events to look for: fever, infections, vomit, epilepsy |
Countries
Vietnam
Outcome results
None listed