Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease
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
- 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 intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Parkinson's Disease
详细描述
This patient funded trial aims to study the safety and efficacy of intranasal installation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Parkinson's Disease. Patients will receive a dose of 4 CCs of AlloEx, approximately 800 billion exosomes, between both nasal cavities. A second equivalent dose will be administered on the subsequent day. 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 Parkinson's Disease
- •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
- •Anticoagulation medicine use
研究组 & 干预措施
Treatment Group (AlloEx)
Intranasal instillations of 4 CCs of AlloEx, approximately 800 billion exosomes. Treatments on back-to-back days, totaling 2 doses.
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