Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured Autologous Bone Marrow-derived Mesenchymal Stem Cells for Compensated Liver Cirrhotic Patient
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The incidence of adverse events
研究概览
简要总结
Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL, patients who are still deemed unsuitable as a candidate for general anesthesia. About 30 mL of autologous bone marrow was collected from the bilateral iliac crests under local anesthesia, heparin was added after collection. In addition, at the Center for Regenerative and Cell Therapy at Yamaguchi University Hospital, a nucleated cell fraction was prepared. Next, a cell suspension was prepared by adding culture medium, and this was inoculated into a culture flask. After subculturing for 3 weeks, the cells were infused through a peripheral vein. The primary endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL,
- •Patients who are still deemed unsuitable as a candidate for general anesthesia.
- •Patients must provide informed consent for study participation.
排除标准
- •Patients with a current history of malignant neoplasm.
- •Patients with gastroesophageal varices at risk of rupture.
- •Patients with renal insufficiency and a serum creatinine ≥2 mg/dL.
- •Patients with a hemoglobin <8 g/dL, a platelet count <50,000/μL, or a prothrombin time <40%.
- •Patients with a performance status of 3 or
- •Patients who refuse to consent to allogeneic blood transfusion.
- •Women who are pregnant.
- •Patients whom their attending physician deems are not suitable candidates for general anesthesia.
- •Patients with a current or previous severe allergic reaction to a contrast agent, beef, cow milk, and anesthesia.
- •Any patient deemed unsuitable for study inclusion by their attending physician.
研究组 & 干预措施
Autologous BMSCs
Infusion of cultured autologous bone marrow derived mesenchymal stem cells
干预措施: Autologous BMSCs (Procedure)
Autologous BMSCs
Infusion of cultured autologous bone marrow derived mesenchymal stem cells
干预措施: bone marrow-derived mesenchymal stem cells (Drug)
结局指标
主要结局
The incidence of adverse events
时间窗: up to 24 weeks the infusion
次要结局
- Subjective symptom scores (SF-36)(up to 24 weeks the infusion)
- Child-Pugh score(up to 24 weeks the infusion)
- Serum albumin levels(up to 24 weeks the infusion)
- Serum fibrosis markers(up to 24 weeks the infusion)
- Improvement or disappearance of lower extremity edema(up to 24 weeks the infusion)
研究者
tarotakami
MD, PhD
Yamaguchi University Hospital