NCT03979898已完成早期 1 期
Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)
R-Bio1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2017年6月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Kaufman Assessment Battery for Children (K-ABC)
研究概览
简要总结
Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP
详细描述
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)
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
- 36 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Astrostem
Experimental
Autologous Adipose Tissue Derived Mesenchymal Stem Cells
干预措施: ASTROSTEM (Biological)
结局指标
主要结局
Kaufman Assessment Battery for Children (K-ABC)
时间窗: Baseline and 12 month
Change from Baseline K-ABC at 12 months
次要结局
- Blood concentration test(Baseline, 1, 3, 6 and 12 month)
- Gross Motor Function Measurement (GMFM)(Baseline, 3, 6 and 12 month)
- Box and Block Test(Baseline, 3, 6 and 12 month)
- Modified Ashworth Scale (MAS)(Baseline, 3, 6 and 12 month)
- SF-36(Baseline, 3, 6 and 12 month)
- Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan(Baseline, 6 and 12 month)
- Kaufman Assessment Battery for Children (K-ABC)(Baseline and 6 month)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.Spinal Cord InjuryNCT01274975R-Bio8
Unknown
1 期
Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage InjuryCartilage DegenerationKnee OsteoarthritisNCT03955497Qilu Hospital of Shandong University30
Unknown
不适用
Treatment of Early Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem CellsKnee OsteoarthritisNCT03956719Qilu Hospital of Shandong University8
已完成
不适用
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb IschemiaCritical Limb IschemiaNCT01663376R-Bio20
已完成
1 期
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord InjurySpinal Cord InjuryNCT01769872R-Bio15