A Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes in Berg Balance Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
UCB + G-CSF
UCB + G-CSF
干预措施: Umbilical cord blood therapy (Procedure)
UCB + G-CSF
UCB + G-CSF
干预措施: Filgrastim (Biological)
结局指标
主要结局
Changes in Berg Balance Scale
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
MinYoung Kim, M.D.
Professor
Bundang CHA Hospital