Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 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 autologous adult adipose derived mesenchymal stem cells versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cells for the treatment of spinal cord injury
详细描述
Studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (SCI). This patient funded trial aims to study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cell for the treatment of SCI. Patients with SCI will receive a single intrathecal injection of AD-MSCs. The total dose will be 100 million cells. 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 Spinal Cord Injury
- •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
Single intrathecal injection of 100 million cells
干预措施: autologous adipose derived mesenchymal stem cells (Biological)
Treatment Group
Single intrathecal injection of 100 million cells
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: American Spinal Injury Association Impairment Scale (ASIA)(Four year follow-up)