跳至主要内容
临床试验/NCT03803241
NCT03803241已完成2 期

Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases That Are Going to be Submitted to a Major Liver Resection

Hospital San Carlos, Madrid2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年5月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
4
试验地点
2
主要终点
Liver volume

研究概览

简要总结

Treatment of patients with metastatic colorectal carcinoma is surgical resection. Only 10-15% of the patients will be candidates for curative resection. After response to chemotherapy this figure rises 10-13% more. To perform the surgery it is necessary to have a sufficient remnant liver volume (RLV), which allows maintaining optimal liver function after resection. If the estimated RLV is insufficient preoperatively, portal venous embolization site (PVE) is performed for compensatory hypertrophy, thus increasing the number of resections 19%. Still, in 20% of these patients surgery can not be performed because RLV is not achieved or because the disease progresses while waiting for growth. Therefore, it is necessary to improve liver regeneration without promoting tumor growth. Studies on liver regeneration, have determined that cells (CD133 +) are involved in the liver hypertrophy that occurs after hepatectomy. CD133 + have been used to induce liver hypertrophy with encouraging results. This population of CD133 +, can be selected from peripheral blood after stimulation with Granulocyte colony-stimulating factor (G-CSF), being able to obtain a large number of them. The investigators propose to treat patients who do not meet criteria for surgery because of insufficient volume <40%, with CD133 + and portal embolization in order to carry out a surgical resection in a second place.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

PVE + CD133

Experimental

preop portal vein embolization + stem cells infusion

干预措施: CD133+ infusion (Drug)

PVE + CD133

Experimental

preop portal vein embolization + stem cells infusion

干预措施: portal vein embolization (Other)

PVE

Sham Comparator

only preop portal vein embolization

干预措施: portal vein embolization (Other)

结局指标

主要结局

Liver volume

时间窗: once residual liver volume reach >40%, an average of 5 weeks.

Liver volume estimated by computed tomography

次要结局

  • Liver volume(Post-surgery follow-up visits the first 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandra Garcia Botella

Principal investigator

Hospital San Carlos, Madrid

研究点 (2)

Loading locations...

相似试验