NCT01933321已完成2 期
Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)
Hospital Universitario Dr. Jose E. Gonzalez2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.
研究概览
简要总结
Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease.
详细描述
There is no more extensive information
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a confirmed diagnosis of ALS according to El Escorial criteria. Diagnosis-time less than four years.
- •Over 18 years old. Forced vital capacity ≥ 40%.
- •One year of evolution.
- •Adequate nutritional state
排除标准
- •Severe bulbar ALS involucre.
- •Inadequate nutritional status.
- •Spondylotic myelopathy, or abnormalities in imaging study.
- •Having concomitant neurological or psychiatric disease.
- •Systemic disease with poor-control.
- •History of treatment with steroids or immunoglobulins in the last year.
- •Participate in the past three months in a Clinical Trial.
- •History of malignancy or cancer today.
- •Intracranial hypertension.
- •Clinical suggestive data of infection in the site of lumbar puncture.
- •Tracheostomy.
- •Use of mechanical ventilation. Forced vital capacity less than 40%. HIV-seropositive or presence of antibodies against hepatitis B or C in the serological studies.
结局指标
主要结局
Evaluation of autologous intrathecal administration of hematopoietic stem cells in patients with ALS.
时间窗: up to 12 months
次要结局
- To evaluate the safety of intrathecal administration of hematopoietic stem cells in patients with ALS.(During the procedure and at 1st, 2nd, 3rd, 6th and 12 th month after the procedure)
研究者
David Gomez Almaguer
Chair of Hematology
Hospital Universitario Dr. Jose E. Gonzalez
研究点 (2)
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