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Completed

NCT Number: NCT03979898

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

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

36 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

KyungHee University Gandong Hospital

Seoul, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASTROSTEM

Biological

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

Primary outcomes

  1. Kaufman Assessment Battery for Children (K-ABC)

    Time frame: Baseline and 12 month

    Change from Baseline K-ABC at 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

R-Bio

Industry

Collaborators

  • Kyung Hee University Hospital at Gangdong

Registry information

Official study title

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

Acronym: CP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2019
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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