Phase 1/2 Study of Autologous Bone Marrow Derived Mononuclear Cells in Liver Cirrhosis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Liver related mortality
研究概览
简要总结
It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis. All the patients have moderate liver disfunction and a waiting time expectancy of liver transplantation longer than 12 months due their low MELD score. The ABMMC are labeled with 99mTc and infused through the hepatic artery. Scintigraphy is performed 2 and 24 hours after infusion. Patients are submitted to frequent clinical, laboratorial and image evaluation during the follow up period of 12 months.
详细描述
A one year clinical trial was conducted. Patients had moderate liver dysfunction and a liver transplant was not expected to occur earlier than 12 months, due to low MELD scores. Hepatocellular carcinoma (HCC) and hepatic artery or portal vein thrombosis were excluded by color Doppler ultrasonography (DUS) and 3-phase computed tomography (CT). Under local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. ABMMC were delivered preferentially in the common hepatic artery by celiac trunk catheterism. Total body scintigraphy (TBS) was performed 3 hours after infusion. Patients were submitted to frequent clinical, biochemical and imaging evaluation during follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis of any origin
- •Moderate liver disfunction (Child-Pugh Score=7-10)
排除标准
- •Waiting time expectancy of liver transplant shorter than 12 months
- •Ongoing hepatic encephalopathy
- •Clinically detectable ascitis
- •Severe coagulation disorder (INR>2,0 or platelets count < 40.000)
- •Diagnosis or strong suspicion of cancer (except basocellular)
- •Pregnancy or intention to become pregnant during the next 12 months
- •Moderate or severe co-morbidity
- •Current participation in another clinical trial
结局指标
主要结局
Liver related mortality
时间窗: 360 days
Hepatic artery and portal vein thrombosis (doppler ultrasound)
时间窗: in days 1,2,7,14,90, 180 and 360
Changes in liver function according to Child-Pugh and MELD scores
时间窗: in days 1,2,7,14,30, 45, 60, 90, 120, 150, 180, 270, 360
Development of liver nodule (ultrasound screening)
时间窗: in days 1,2,7,14,90, 180 and 360 (US) and in day 360 (CT scan )
次要结局
- Body distribution of 99mTc labeled BMDMC (scintigraphy)(after 3 hours of infusion)