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

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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Biological: ASTROSTEM

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)

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • KyungHee University Gandong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Astrostem; 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; Other Names: Autologous Adipose Tissue Derived Mesenchymal Stem Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaufman Assessment Battery for Children (K-ABC)	Change from Baseline K-ABC at 12 months	Baseline and 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood concentration test	Change from baseline concentration of dopamine, acetylcholine, serotonin at 1, 3, 6 and 12 month	Baseline, 1, 3, 6 and 12 month
Gross Motor Function Measurement (GMFM)	Change from Baseline GMFM at 12 months	Baseline, 3, 6 and 12 month
Box and Block Test	Change from Baseline Box and block test at 12 months	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	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	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	Baseline, 6 and 12 month
Kaufman Assessment Battery for Children (K-ABC)	Change from Baseline K-ABC at 6 months	Baseline and 6 month

Collaborators and Investigators

• Sponsor: R-Bio
• Collaborators: Kyung Hee University Hospital at Gangdong

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2017
• Primary Completion (ACTUAL): April 23, 2019
• Study Completion (ACTUAL): May 13, 2019

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (ACTUAL): June 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: biostar-CP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No