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OpenTrials
Completed

NCT Number: NCT02236065

Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders

This open label trial is conducted to investigate the efficacy and safety of the combination therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor (G-CSF) for patients with brain injury or neurodegenerative disorders.

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Key information

Conditions

Brain Injury Amyotrophic Lateral Sclerosis Basal Ganglia Diseases Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Cerebral Palsy Craniocerebral Trauma Metabolic Diseases Motor Neuron Disease Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Proteostasis Deficiencies Spinal Cord Diseases Synucleinopathies TDP-43 Proteinopathies Trauma, Nervous System Wounds and Injuries

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 463-712, South Korea

About this study

Current treatments for brain injury or neurodegenerative disorders are palliative rather than curative. Preclinical and some clinical studies suggest that UCB and G-CSF can be used as restorative approach for such disorders.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

should be included one of the 4 disorders

  • Brain injury: onset duration over 12 months, Age: 19 years or over
  • Cerebral palsy: spastic, dyskinetic or ataxic, Age: 19 years or over
  • Parkinson's disease: modified Hoehn and Yahr stage 2.5, 3, 4, Age: 30 to 75 years
  • ALS: definite of possible ALS, progression during the past 6 months, Age: 19 to 65

Exclusion criteria

  • Uncontrolled pulmonary, renal dysfunction at enrollment
  • Uncontrolled seizure
  • Malignant cancer
  • Possibility of hypersensitivity to drugs used in this study
  • Contraindication to the study intervention or assessment
  • Pregnant or breast feeding women
  • Non-compliance with the study visits specified in the protocol

Treatment and study plan

Umbilical Cord Blood therapy

Procedure

filgrastim

Biological

Primary outcomes

  1. Changes in Berg Balance Scale

    Time frame: Baseline - 1 month - 3 months - 6 months

    Berg Balance Scale for brain injury and parkinson's disease (range: 0 to 56, Higher scores indicates better balance function.)

  2. Changes in the Level of Disability

    Time frame: Baseline - 1 month - 3 months - 6 months

    FIM (Functional Independence Measure) for brain injury and cerebral palsy (range: 18 to 126, Higher scores indicate more independence in activities of daily living.)

  3. Changes in Standardized Gross Motor Function

    Time frame: Baseline - 1 month - 3 months - 6 months

    GMFM (Gross Motor Function Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better gross motor function.)

  4. Changes in Motor Performance

    Time frame: Baseline - 1 month - 3 months - 6 months

    GMPM (Gross Motor Performance Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better motor quality.)

  5. Changes in ALSFRS-R

    Time frame: Baseline - 1 month - 3 months - 6 months

    ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised) for ALS (range: 0 to 48, Higher scores indicate better physical function.)

  6. Changes in UPDRS

    Time frame: Baseline - 1 month - 3 months - 6 months

    UPDRS (Unified Parkinson's Disease Rating Scale) for parkinson's disease (Part 1: mentation, behavior and mood; Part 2: activities of daily living; Part 3: motor examination; Part 4: complications of therapy; Part 5: Schwab and England activities of daily living scale)

Secondary outcomes

  1. Changes in Brain MRI

    Time frame: Baseline - 6 months

    Analysis of Diffusion Tensor Image (DTI) for brain injury, cerebral palsy, ALS

  2. Changes in Brain PET

    Time frame: Baseline - 6 months

    for parkinson's disease

  3. Number of adverse events and participants with those adverse events

    Time frame: 6 months

    The numbers of adverse events and subjects with those serious adverse events within each group; A serious adverse event is any untoward medical occurrence that at any dose: results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect.

Sponsors and collaborators

Lead sponsor

MinYoung Kim, M.D.

Other

Registry information

Official study title

A Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative Disorders

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2014
Registry last updated
Oct 12, 2017

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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