NCT05472428已完成1 期
Autologous Bone Marrow Mononuclear Cell Administration in the Treatment of Neurologic Sequela in Children With Spina Bifida
Vinmec Research Institute of Stem Cell and Gene Technology2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2016年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Adverse events and serious adverse events
研究概览
简要总结
The aim of this study was to evaluate the safety and efficacy of autologous bone marrow mononuclear cell infusion in the management of neurological sequelae in children with spina bifida
详细描述
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear cells in 11 patients with spina bifida at Vinmec Research Institute of Stem Cell and Gene Technology in Hanoi, Vietnam from 2016 to 2020
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
盲法说明
Open Label
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient who was diagnosed with lumbar spina bifida underwent spinal cord close-up surgery.
- •Both genders.
- •Aged between 6 months and 15 years old.
- •Exhibited bowel disorders (constipation, fecal incontinence) and urinary dysfunction (urinary retention or leakage).
排除标准
- •Vertebrae clefts in the chest, neck, and other spinal locations.
- •Coagulopathy.
- •Acute and chronic infection.
- •Kidney function disorder, liver failure
- •Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).
结局指标
主要结局
Adverse events and serious adverse events
时间窗: up to the 12-month period following treatment
Incidence of the adverse events or serious adverse events after infusion
次要结局
- Lower limb motor functions(up to the 12-month period following treatment)
- Rectoanal inhibitory reflex(up to the 12-month period following treatment)
- Bladder sensation(up to the 12-month period following treatment)
- Urinary retention(up to the 12-month period following treatment)
- Bristol stool scale(up to the 12-month period following treatment)
- Urinary incontinence(up to the 12-month period following treatment)
研究者
研究点 (2)
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