Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, Stem Cells
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.
Interventions
BIOLOGICALAutologous Bone Marrow Mononuclear Cells
Transplantation of Autologous Bone Marrow Mononuclear Cells
Sponsors
Vinmec Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score of Gross Motor Function Measure (GMFM)-88 | 3 months and 6 months after transplantation | GMFM-88 |
| Change in Gross Motor Function Measure (GMFM)-66 Percentile | 3 months and 6 months after transplantation | GMFM-66 percentile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle tone | 3 months 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: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy |
Countries
Vietnam
Outcome results
None listed