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

R-Bio1 site in 1 country1 target enrollmentJune 15, 2017

ConditionsCerebral Palsy

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Cerebral Palsy
Sponsor: R-Bio
Enrollment: 1
Locations: 1
Primary Endpoint: Kaufman Assessment Battery for Children (K-ABC)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

June 15, 2017

End Date

May 13, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

R-Bio

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Kaufman Assessment Battery for Children (K-ABC)

Time Frame: Baseline and 12 month

Change from Baseline K-ABC at 12 months

Secondary Outcomes

Blood concentration test(Baseline, 1, 3, 6 and 12 month)
Gross Motor Function Measurement (GMFM)(Baseline, 3, 6 and 12 month)
Box and Block Test(Baseline, 3, 6 and 12 month)
Modified Ashworth Scale (MAS)(Baseline, 3, 6 and 12 month)
SF-36(Baseline, 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)
Kaufman Assessment Battery for Children (K-ABC)(Baseline and 6 month)