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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ASTROSTEM
Sponsored by
R-Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

36 Months - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • KyungHee University Gandong Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Astrostem

Arm Description

Autologous Adipose Tissue Derived Mesenchymal Stem Cells

Outcomes

Primary Outcome Measures

Kaufman Assessment Battery for Children (K-ABC)
Change from Baseline K-ABC at 12 months

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2016
Last Updated
June 6, 2019
Sponsor
R-Bio
Collaborators
Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT03979898
Brief Title
Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP
Acronym
CP
Official Title
Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
April 23, 2019 (Actual)
Study Completion Date
May 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
Collaborators
Kyung Hee University Hospital at Gangdong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Astrostem
Arm Type
Experimental
Arm Description
Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Intervention Type
Biological
Intervention Name(s)
ASTROSTEM
Other Intervention Name(s)
Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Intervention Description
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
Primary Outcome Measure Information:
Title
Kaufman Assessment Battery for Children (K-ABC)
Description
Change from Baseline K-ABC at 12 months
Time Frame
Baseline and 12 month
Secondary Outcome Measure Information:
Title
Blood concentration test
Description
Change from baseline concentration of dopamine, acetylcholine, serotonin at 1, 3, 6 and 12 month
Time Frame
Baseline, 1, 3, 6 and 12 month
Title
Gross Motor Function Measurement (GMFM)
Description
Change from Baseline GMFM at 12 months
Time Frame
Baseline, 3, 6 and 12 month
Title
Box and Block Test
Description
Change from Baseline Box and block test at 12 months
Time Frame
Baseline, 3, 6 and 12 month
Title
Modified Ashworth Scale (MAS)
Description
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
Time Frame
Baseline, 3, 6 and 12 month
Title
SF-36
Description
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
Time Frame
Baseline, 3, 6 and 12 month
Title
Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan
Description
Changes in fMRI & MRS scan from baseline to 6, 12 month
Time Frame
Baseline, 6 and 12 month
Title
Kaufman Assessment Battery for Children (K-ABC)
Description
Change from Baseline K-ABC at 6 months
Time Frame
Baseline and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
KyungHee University Gandong Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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