Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety (adverse events)
研究概览
简要总结
This trial will study the safety and efficacy of intrathecal injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of amyotrophic lateral sclerosis
详细描述
Amyotrophic lateral sclerosis is a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and can improve the prognosis of afflicted patients. Patients with ALS will receive three intrathecal injections of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The dose for each injection will be 50 million cells and the injections will be at two-month intervals. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Amyotrophic Lateral Sclerosis.
- •Understanding and willingness to sign a written informed consent document
排除标准
- •Active infection
- •Active cancer
- •Chronic multisystem organ failure
- •Pregnancy
- •Anticoagulation medicine use
- •Clinically significant Abnormalities on pre-treatment laboratory evaluation
- •Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
- •Previous organ transplant
- •Hypersensitivity to sulfur
- •Continued drug abuse
- •Pre-menopausal women not using contraception
研究组 & 干预措施
Treatment Group
three intrathecal injections of 50 million cells at two-month intervals.
干预措施: AlloRx (Biological)
结局指标
主要结局
Safety (adverse events)
时间窗: Four year follow-up
Clinical monitoring of possible adverse events or complications
次要结局
- Efficacy: revised ALS functional rating scale (ALSFRS-R)(Four year follow-up)