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

Cerebral Palsy Clinical Trial

— CP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979898
• Other study ID #: biostar-CP
• Status: Completed
• Phase: Early Phase 1
• Start date: June 15, 2017
• Est. completion date: May 13, 2019

Study information

• Verified date: June 2019
• Source: R-Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 13, 2019
• Est. primary completion date: April 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	KyungHee University Gandong Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
R-Bio	Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaufman Assessment Battery for Children (K-ABC)	Change from Baseline K-ABC at 12 months	Baseline and 12 month
Secondary	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
Secondary	Gross Motor Function Measurement (GMFM)	Change from Baseline GMFM at 12 months	Baseline, 3, 6 and 12 month
Secondary	Box and Block Test	Change from Baseline Box and block test at 12 months	Baseline, 3, 6 and 12 month
Secondary	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
Secondary	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
Secondary	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
Secondary	Kaufman Assessment Battery for Children (K-ABC)	Change from Baseline K-ABC at 6 months	Baseline and 6 month