Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for the Treatment of Stroke
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 intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Stroke
详细描述
This patient funded trial aims to study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Stroke. Patients will receive intranasal instillations between both nasal cavities of UC-MSC exosomes. The total dose will be 4 CC of AlloEx, approximately 800 billion exosomes, for each day. Patients will receive instillations on back-to-back days totaling 2 doses. 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 an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own 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 Stroke
- •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 (AlloEx)
Intranasal instillations of 4 CCs of AlloEx between both nasal cavaties, which is approximately 800 billion exosomes in total. Second dose of 4 CCs to be receive the following day.
干预措施: AlloEx (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
未报告次要终点