Hepatic Artery Infusion of CD34+ Cells, Isolated by the Isolex 300i Device, in Stem Cell Transplant Recipients With Hepatic Failure Due to Veno-occlusive Disease
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Learn if donor's cells can produce liver cells when injected directly into the liver and whether this procedure will improve liver function and survival.
研究概览
简要总结
The primary objective is to determine whether donor stem cells administered via hepatic artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem cell transplantation (SCT) and the safety of this procedure. The secondary objective is to improve liver function and improve survival.
详细描述
Participants in this study have received stem cell transplantation. As a result of this procedure, participants have developed severe liver dysfunction. Researchers have recently discovered that cells circulating in the blood and bone marrow are capable of forming liver cells. Before taking part in this study, women able to have children must have a negative blood pregnancy test.
Participants in this study will have donor's cells infused directly into their liver through a catheter that will be inserted through the groin. This will be done after liver disease has been diagnosed by liver biopsy. The catheter will stay in the groin for no more than 3 days. During that time, participants will be exposed to repeated x-ray exams to ensure that the catheter stays in place.
During the time that the catheter is in place, the infusion will be repeated as long as donor's cells are available. Participants will receive different drugs by vein to decrease the risk of transfusion reaction. After completing donor cell infusion, the catheter will be removed.
After participants are released from the hospital, they will have periodic evaluation of liver size. About 1 teaspoon of blood will be drawn for standard blood tests to evaluate liver function. Around Days 28 and 90, participants will have liver biopsy.
This is an investigational study. A total of 10 patients will take part in this study. All will be enrolled at UTMDACC.
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
- •SCT recipients with severe hepatic dysfunction (bilirubin equal to or greater than 5mg/dl) and histologically documented VOD.
- •The original stem cell donor must be sex-mismatched, willing and able to donate G-CSF-mobilized peripheral blood stem cells.
- •The patient must have complete donor chimerism.
排除标准
- •Patients who do not have at least 5 x 10^6 donor CD34+ cells/kg available for infusion.
- •Patients with graft versus host disease (GVHD).
- •Patients in whom hepatic artery infusion cannot be performed because of anatomical or technical reasons.
- •Patients with active hepatitis B or C.
研究组 & 干预措施
Hepatic Artery Infusion
Donor-derived CD34+ cells administered in a total volume of 100ml via hepatic artery over 10 minutes. Cells given as a dose escalation study. First cohort of 3 patients receive 1 * 106 CD34+ cells/kg. Next 3 patients receive 2.5 * 106 CD34+cells/kg. Next 3 patients receive 5 * 106 CD34+ cells/kg. Less than 1 * 105 T cells/kg administered.
干预措施: Hepatic artery infusion of CD34+ cells (Procedure)
Hepatic Artery Infusion
Donor-derived CD34+ cells administered in a total volume of 100ml via hepatic artery over 10 minutes. Cells given as a dose escalation study. First cohort of 3 patients receive 1 * 106 CD34+ cells/kg. Next 3 patients receive 2.5 * 106 CD34+cells/kg. Next 3 patients receive 5 * 106 CD34+ cells/kg. Less than 1 * 105 T cells/kg administered.
干预措施: Cobe Spectra (Device)
结局指标
主要结局
Learn if donor's cells can produce liver cells when injected directly into the liver and whether this procedure will improve liver function and survival.
时间窗: 3 Years
次要结局
未报告次要终点