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

Biostar Stem Cell Research Institute (R-Bio)

Status and phase

Completed

Early Phase 1

Conditions

Cerebral Palsy

Treatments

Biological: ASTROSTEM

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03979898

biostar-CP

Details and patient eligibility

About

Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP

Full 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)

Enrollment

1 patient

Sex

All

Ages

36 months to 12 years old

Volunteers

No Healthy Volunteers

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