NCT01504594暂停1 期
Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy
Hospital Universitario Dr. Jose E. Gonzalez2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
研究概览
简要总结
The purpose of this study is to determine whether an autologous stem cell infusion through catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy.
Process:
- Primary Evaluation
- Clinical History
- Echocardiogram to evaluate ejection fraction and other parameters
- Signing of Informed Consent and clearing doubts
- Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously
- On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by hematologists through posterior iliac crests(amount calculated at 8cc/kg, without exceeding 150ml).
- Recovery room with family members while the cells are being processed in the Hematology Laboratory.
- Approximately 3 hours after the 1st procedure, the patient re-enters the operation room, which is equipped for cardiac catheterization, so that cardiologists infuse the stem cells through the femoral artery into the coronary arteries which irrigate the heart´s muscle fibers.
- Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids.
- Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.
详细描述
- The Patient will receive standard surgical care, accompanied by a nurse at all times.
- Premedication includes: Omeprazole (gastric protector), Ketorolac (anti-pain and swelling), ondansetron (antivomiting).
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
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ejection fraction less than 35 percent in echocardiogram
- •More than 3 months with complete medical treatment without significant improvement
- •Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers
排除标准
- •Not signing informed consent
- •Active infection at enrolling time
- •Inadequate G-CSF application
结局指标
主要结局
Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.
时间窗: 6 weeks
Patient will be assessed to prove that the procedure did not cause any deterioration of his/her health presented at the beginning of the study.
次要结局
- Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.(6 months)
研究者
Consuelo Mancias Guerra
Pediatric Hematology Professor
Hospital Universitario Dr. Jose E. Gonzalez
研究点 (2)
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