A Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative Disorders
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Brain Injury
- Sponsor
- MinYoung Kim, M.D.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Changes in Berg Balance Scale
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
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.
Investigators
MinYoung Kim, M.D.
Professor
Bundang CHA Hospital
Eligibility 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
Outcomes
Primary Outcomes
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.)
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.)
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.)
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.)
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.)
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
- Changes in Brain MRI(Baseline - 6 months)
- Changes in Brain PET(Baseline - 6 months)
- Number of adverse events and participants with those adverse events(6 months)