Cerebral Palsy
Conditions
Brief summary
Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP
Detailed description
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Cerebral Palsy(CP)
Interventions
BIOLOGICALASTROSTEM
Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10\^7cells/5mL 15kg \ 25kg : 1x10\^8cells/10mL 25kg over : 1.5x10\^8cells/15mL
Sponsors
Kyung Hee University Hospital at Gangdong
R-Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
36 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children with spastic cerebral palsy of spastic paraplegia or quadriplegia involving the two side occurred at birth or before birth * Age : 36 months - 12 year, males and females * Subjects who understand and sign the consent form for this study * Kaufman Assessment Battery for Children 50\<K-ABC\<100
Exclusion criteria
* The last three months had seizures or epilepsy patients taking the durg * Genetic Diseases * Recent cancer patients within 1 year * patients witn a psychiatric disorder that may interfere in the clinical trial * participating another clinical trials within 3 months * Recently there is a change of the abrupt symptoms within three months of the patient * Subjects with a infectious disease include HIV and VDRL * Patients who penicillin hypersensitivity reactions * Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kaufman Assessment Battery for Children (K-ABC) | Baseline and 12 month | Change from Baseline K-ABC at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measurement (GMFM) | Baseline, 3, 6 and 12 month | Change from Baseline GMFM at 12 months |
| Box and Block Test | Baseline, 3, 6 and 12 month | Change from Baseline Box and block test at 12 months |
| Modified Ashworth Scale (MAS) | Baseline, 3, 6 and 12 month | * Measurement of resistance during soft-tissue stretching * Scale range is 0(no increase in muscle ton) to 4(affected part rigid in flexion or extension) * Change from Baseline MAS at 12 months |
| Blood concentration test | Baseline, 1, 3, 6 and 12 month | Change from baseline concentration of dopamine, acetylcholine, serotonin at 1, 3, 6 and 12 month |
| Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan | Baseline, 6 and 12 month | Changes in fMRI & MRS scan from baseline to 6, 12 month |
| Kaufman Assessment Battery for Children (K-ABC) | Baseline and 6 month | Change from Baseline K-ABC at 6 months |
| SF-36 | Baseline, 3, 6 and 12 month | * SF-36 is a survey to measure Mental & Physical Health * Score range is 0 to 100(the lower the score, the more disability) * Change from Baseline SF-36 at 12 months |
Countries
South Korea
Outcome results
None listed