Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP

Early Phase 1CompletedNCT03979898

R-Bio1 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

ASTROSTEMBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 36 MonthsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

KyungHee University Gandong Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Kaufman Assessment Battery for Children (K-ABC)

Change from Baseline K-ABC at 12 months

Time frame: Baseline and 12 month

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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