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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03979898
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Kyung Hee University Hospital at Gangdong
Information provided by (Responsible Party):
R-Bio

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979898


Locations
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Korea, Republic of
KyungHee University Gandong Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
R-Bio
Kyung Hee University Hospital at Gangdong

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Responsible Party: R-Bio
ClinicalTrials.gov Identifier: NCT03979898     History of Changes
Other Study ID Numbers: biostar-CP
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases