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

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: NCT02236065
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Injury Cerebral Palsy Amyotrophic Lateral Sclerosis Parkinson's Disease Procedure: Umbilical cord blood therapy Biological: Filgrastim Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: UCB + G-CSF
UCB + G-CSF
Procedure: Umbilical cord blood therapy
Biological: Filgrastim



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02236065


Locations
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Korea, Republic of
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
MinYoung Kim, M.D.
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Responsible Party: MinYoung Kim, M.D., Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT02236065    
Other Study ID Numbers: UCBnG-CSF
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Keywords provided by MinYoung Kim, M.D., Bundang CHA Hospital:
Umbilical cord blood
Granulocyte-colony stimulating factor
Brain injury
Neurodegenerative disorder
Efficacy
Safety
Additional relevant MeSH terms:
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Parkinson Disease
Brain Injuries
Cerebral Palsy
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Wounds and Injuries
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic
Neuromuscular Diseases
Spinal Cord Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs