A Phase I Safety and Pharmacodynamic Study of Intravenous Infusion of PLX-PAD Cells in Patients With PAH
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Incidence of treatment-emergent AEs (frequency and severity at each dose level)
研究概览
简要总结
The purpose of this clinical study is to assess the safety of PLX-PAD to treat pulmonary arterial hypertension (PAH). PLX-PAD is a cell-based product made of allogeneic Mesenchymal-like Adherent Stromal Cells (ASCs), derived from human full-term placentas following an elective caesarean section. This year-long study will evaluate the safety of three different dose levels of PLX-PAD, each given as a single intravenous infusion. This study will also evaluate effects that PLX-PAD may have on PAH, such as changes in the ability to exercise and on other tests used to measure the disease severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
0.5 M PLX-PAD
0.5 million (M) PLX-PAD cells per kg body weight
干预措施: PLX-PAD (Drug)
1 M PLX-PAD
1.0 million (M) PLX-PAD cells per kg body weight
干预措施: PLX-PAD (Drug)
2 M PLX-PAD
2.0 million (M) PLX-PAD cells per kg body weight
干预措施: PLX-PAD (Drug)
结局指标
主要结局
Incidence of treatment-emergent AEs (frequency and severity at each dose level)
时间窗: 12 weeks
Incidence of SAEs
时间窗: 1 year
次要结局
- Change in Six Minute Walk distance(Baseline and 6 weeks)
- Change in Dyspnea Score(Baseline and 6 weeks)
- Change from Baseline in echocardiography parameters(Baseline and 6 weeks)
- Change in WHO Functional Classification(Baseline and 6 weeks)
- Change in cardiopulmonary hemodynamics(Baseline and 6 weeks)
- Change in Plasma NT-pro-BNP levels(Baseline and 6 weeks)