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临床试验/NCT01591200
NCT01591200已完成2 期

A Parallel Group Randomized Open Blinded End Point Evaluation, Multicentric, Dose Escalation, Phase -II Study Assessing the Safety and Efficacy of Intraarterial (Hepatic) Ex-vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Alcoholic Liver Cirrhosis

Stempeutics Research Pvt Ltd20 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
20
主要终点
Safety

研究概览

简要总结

This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension).
  • Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and <14).
  • MELD scores of at least 10 (UNOS Meld calculator).
  • Normal AFP Level
  • Hb>10gm/dl.
  • Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
  • Signed informed consent.

排除标准

  • Patients likely to undergo liver transplantation during the duration of the study.
  • Presence of advanced hepatic encephalopathy Grades 3 & 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening
  • Active variceal bleed.
  • Refractory ascites.
  • Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
  • Platelet count < 30,000/mm
  • Serum Sodium <129mEq/L.
  • Serum Creatinine > 2 mg/dl.
  • Hepatocellular carcinoma or other malignancies
  • Active infectious disease.
  • Presence of severe underlying cardiac, pulmonary or renal disease.
  • Excessive alcohol (>30 gm of alcohol/day) use in the last 3 months before screening.
  • Positive HbSAg or antibodies to HIV or HCV.
  • Pregnancy or lactation.
  • Participation in other clinical trials.
  • Unwilling/unable to sign the informed consent.

结局指标

主要结局

Safety

时间窗: 2 years

The type of adverse events, number of adverse events and proportion of patients with adverse events

次要结局

  • Liver function tests.(2 years)
  • CT scan of abdomen.(2 years)
  • Change in MELD score(2 years)
  • Improvement in quality of life as assessed by SF 36 questionnaire(2 years)
  • Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA(6 Months)
  • Change in Child-Pugh score(2 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (20)

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