Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
- 主要终点
- Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.
研究概览
简要总结
This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.
详细描述
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 y/o
- •CHF with EF > 35%
- •Bilirubinemia, serum transaminase> 2.5 times normal max level
- •Creatininemia > 2.5 times max level
- •NYHA Class > 3
- •Negative pregnancy test (for women in fertile age)
排除标准
- •Impossibility to harvest the bone marrow
- •Pregnancy or breast-feeding
- •History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas)
- •Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.
结局指标
主要结局
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.
时间窗: 1 YEAR
次要结局
- Secondary target: determine clinical effects of grafted cells on remodeling pathology.(1 YEAR)