Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP
- Conditions
- Cerebral Palsy
- Interventions
- Biological: ASTROSTEM
- Registration Number
- NCT03979898
- Lead Sponsor
- R-Bio
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Astrostem ASTROSTEM Autologous Adipose Tissue Derived Mesenchymal Stem Cells
- Primary Outcome Measures
Name Time Method Kaufman Assessment Battery for Children (K-ABC) Baseline and 12 month Change from Baseline K-ABC at 12 months
- Secondary Outcome Measures
Name Time Method Kaufman Assessment Battery for Children (K-ABC) Baseline and 6 month Change from Baseline K-ABC at 6 months
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
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
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 monthsSF-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
Trial Locations
- Locations (1)
KyungHee University Gandong Hospital
🇰🇷Seoul, Korea, Republic of