Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 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 intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Systemic Sclerosis
详细描述
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Systemic Sclerosis. Patients with Systemic Sclerosis will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. 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.
For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis.
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 Systemic Sclerosis
- •Understanding and willingness to sign a written informed consent document
排除标准
- •Active infection
- •Active cancer
- •Chronic multisystem organ failure
- •Pregnancy
- •Clinically significant Abnormalities on pre-treatment laboratory evaluation
- •Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
- •Continued drug abuse
- •Pre-menopausal women not using contraception
- •Previous organ transplant
- •Hypersensitivity to sulfur
研究组 & 干预措施
Treatment Group
Single intravenous infusion 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: skin score(Four year follow-up)
- Efficacy: Forced vital capacity (FVC)(Four year follow-up)