A Safety and Efficacy Study of Autologous Bone Marrow Cell Infusion Therapy in HIV Infected Patients With Advanced Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Post-transplantation prognosis for cirrhosis
研究概览
简要总结
An international investigation to evaluate if, and if so how long, autologous bone marrow hematopoietic stem cell transplantation can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.
详细描述
An international investigation to evaluate if, and if so how long, autologous bone marrow (ABM) hematopoietic stem cell transplantation (HSCT) can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine who meet all criteria following:
- •have cirrhosis with 7 or higher Child-Pugh Score in Child-Pugh Score B
- •able to consent and willing to participate in the study
- •under good control for HIV infection
排除标准
- •Cases applicable to ANY condition of the following:
- •Hepatocellular carcinoma (HCC), except for cases having been completely treated without history of recurrence
- •Malignant tumors other than HCC
- •Alcoholic liver disease (ALD)
- •Hemoglobin under 8g/dL or Platelets under 20/ml at the registration
- •Esophageal or gastric varices with a risk of bursting, except for cases with only cured history of such conditions
- •Cases that cannot obtain the informed consent to autologous blood transfusion
- •Pregnancy
- •Renal dysfunction with 2mg/dL or higher serum creatinine
- •Performance Status 3 or 4 (assessment excludes hemophilic arthritis related daily life limitations)
- •Cases not fit for general anesthesia
- •Other conditions considered not suitable for the study by doctors
研究组 & 干预措施
Hematopoietic stem cell transplantation
Extraction of bone marrow cells from HIV positive patients with advanced liver cirrhosis and transplant their bone marrow back into the patients
干预措施: Hematopoietic stem cell transplantation (Procedure)
结局指标
主要结局
Post-transplantation prognosis for cirrhosis
时间窗: 24 weeks
Evaluate statistical significance between pre-transplantation and 24 weeks after in: * Child-Pugh score * albumin * serum fibrosis markers * Transient Elastography (TM) * ascites imagery * SF-36v2(TM) Health Survey. Because advanced liver cirrhosis is a progressive condition itself, treatment efficacy is defined by "improvement" and "no change" in the indicators listed.
次要结局
- Duration of the treatment efficacy(After 24 weeks up to 48 weeks)