NCT00641836已完成不适用
One-Year Follow-Up of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension
Zhejiang University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2005年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
研究概览
简要总结
Recent researches indicate that impairment of vascular and endothelial homeostasis plays a major role in the initiation and development of IPAH.We have recently reported the safety and feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such therapy. To help answer these questions, we designed the one year follow-up to investigate the safety and efficacy of autologous EPCs injection in patients with IPAH.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria included a base-line six minute walking distance between 100 and 450 m
- •A resting mean pulmonary-artery pressure greater than 30 mm Hg
- •A pulmonarycapillary wedge pressure of less than 15 mm Hg
- •Pulmonary vascular resistance greater than 240 dyn•sec•cm-5
- •18-60 years old
排除标准
- •The exclusion criteria included secondary pulmonary hypertension as a result of heart disease
- •Pulmonary disease
- •Sleep-associated disorders
- •Chronic thromboembolic disease
- •Autoimmune or collagen vascular disease
- •HIV infection
- •Liver disease
- •New York Heart Association functional class IV
- •Major bleeding requiring blood transfusion
- •Renal dysfunction
- •Evidence for malignant diseases were excluded
研究者
研究点 (1)
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