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出境医 / 临床实验 / 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 CP (CP)

Study Description
Brief Summary:
Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP

Condition or disease Intervention/treatment Phase
Cerebral Palsy Biological: ASTROSTEM Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : April 23, 2019
Actual Study Completion Date : May 13, 2019
Arms and Interventions
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 Name: Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Outcome Measures
Primary Outcome Measures :
  1. Kaufman Assessment Battery for Children (K-ABC) [ Time Frame: Baseline and 12 month ]
    Change from Baseline K-ABC at 12 months


Secondary Outcome Measures :
  1. Blood concentration test [ Time Frame: Baseline, 1, 3, 6 and 12 month ]
    Change from baseline concentration of dopamine, acetylcholine, serotonin at 1, 3, 6 and 12 month

  2. Gross Motor Function Measurement (GMFM) [ Time Frame: Baseline, 3, 6 and 12 month ]
    Change from Baseline GMFM at 12 months

  3. Box and Block Test [ Time Frame: Baseline, 3, 6 and 12 month ]
    Change from Baseline Box and block test at 12 months

  4. Modified Ashworth Scale (MAS) [ Time Frame: Baseline, 3, 6 and 12 month ]
    • 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

  5. SF-36 [ Time Frame: Baseline, 3, 6 and 12 month ]
    • 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

  6. Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan [ Time Frame: Baseline, 6 and 12 month ]
    Changes in fMRI & MRS scan from baseline to 6, 12 month

  7. Kaufman Assessment Battery for Children (K-ABC) [ Time Frame: Baseline and 6 month ]
    Change from Baseline K-ABC at 6 months


Eligibility Criteria
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Ages Eligible for Study:   36 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
KyungHee University Gandong Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
R-Bio
Kyung Hee University Hospital at Gangdong
Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date June 7, 2019
Actual Study Start Date  ICMJE June 15, 2017
Actual Primary Completion Date April 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019) 		Kaufman Assessment Battery for Children (K-ABC) [ Time Frame: Baseline and 12 month ]
Change from Baseline K-ABC at 12 months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Blood concentration test [ Time Frame: Baseline, 1, 3, 6 and 12 month ]
    Change from baseline concentration of dopamine, acetylcholine, serotonin at 1, 3, 6 and 12 month
  • Gross Motor Function Measurement (GMFM) [ Time Frame: Baseline, 3, 6 and 12 month ]
    Change from Baseline GMFM at 12 months
  • Box and Block Test [ Time Frame: Baseline, 3, 6 and 12 month ]
    Change from Baseline Box and block test at 12 months
  • Modified Ashworth Scale (MAS) [ Time Frame: Baseline, 3, 6 and 12 month ]
    • 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
  • SF-36 [ Time Frame: Baseline, 3, 6 and 12 month ]
    • 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
  • Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan [ Time Frame: Baseline, 6 and 12 month ]
    Changes in fMRI & MRS scan from baseline to 6, 12 month
  • Kaufman Assessment Battery for Children (K-ABC) [ Time Frame: Baseline and 6 month ]
    Change from Baseline K-ABC at 6 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP
Official Title  ICMJE Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE 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 Name: Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Study Arms  ICMJE Experimental: Astrostem
Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Intervention: Biological: ASTROSTEM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2019) 		1
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 13, 2019
Actual Primary Completion Date April 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 36 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979898
Other Study ID Numbers  ICMJE biostar-CP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party R-Bio
Study Sponsor  ICMJE R-Bio
Collaborators  ICMJE Kyung Hee University Hospital at Gangdong
Investigators  ICMJE Not Provided
PRS Account R-Bio
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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