An Early Phase 1 interventional study of ASTROSTEM in Cerebral Palsy, sponsored by R-Bio. Completed at 1 site in South Korea. Open to participants aged 36 Months to 12 Years. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by R-Bio · Early Phase 1, Interventional, and Treatment
Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP
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)
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's enrollment of 1 is below the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →R-Bio is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Biological: ASTROSTEM
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
Also known as: Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Kaufman Assessment Battery for Children (K-ABC)
Change from Baseline K-ABC at 12 months
Time frame: Baseline and 12 month
Blood concentration test
Change from baseline concentration of dopamine, acetylcholine, serotonin at 1, 3, 6 and 12 month
Time frame: Baseline, 1, 3, 6 and 12 month
Gross Motor Function Measurement (GMFM)
Change from Baseline GMFM at 12 months
Time frame: Baseline, 3, 6 and 12 month
Box and Block Test
Change from Baseline Box and block test at 12 months
Time frame: Baseline, 3, 6 and 12 month
Modified Ashworth Scale (MAS)
* 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
Time frame: Baseline, 3, 6 and 12 month
SF-36
* 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
Time frame: Baseline, 3, 6 and 12 month
Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan
Changes in fMRI \& MRS scan from baseline to 6, 12 month
Time frame: Baseline, 6 and 12 month
Kaufman Assessment Battery for Children (K-ABC)
Change from Baseline K-ABC at 6 months
Time frame: Baseline and 6 month
Plan to share: No
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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