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临床试验/NCT03516006
NCT03516006Unknown1 期

Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

Fuzhou General Hospital0 个研究点目标入组 20 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
20
主要终点
adverse effects regarding UCMSC infusion

研究概览

简要总结

Primary sclerosing cholangitis (PSC) is an idiopathic condition with intrahepatic cholangitis and fibrosis, leading to multifocal bile duct stricture. Its main clinical manifestations are chronic cholestatic lesions and is deemed as autoimmune liver disease. PSC are immune abnormalities that occurs in patients with genetic susceptibility. No other pathogenesis is revealed yet. Ursodeoxycholic acid is used as an empirical treatment, and there is no approved drug or a acceptable treatment regimen. The disease often progresses to liver decompensation and requires liver transplantation. In recent years, the clinical application of stem cell therapy has seen many important advances. Stem cells are characterized with properties of multiple differentiation, repair of damaged tissue and immuno-modulation. This study aims to employ UCMSCs to treat PSC patients and observe its efficacy and safety, and to explore the possible therapeutic mechanisms.

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

  • progressive PSC
  • willing to give consent

排除标准

  • decompensated liver cirrhosis
  • total serum bilirubin >5ULN
  • refractory ascites
  • serum creatinine >1.5mg/dL
  • Cirrhotic nodules with malignant tendencies
  • primary biliary cholangitis
  • IgG4-associated sclerosing cholangitis
  • non-PSC induced bile duct stones
  • biliary tract trauma
  • recurrent suppurative cholangitis
  • neoplastic disease
  • pancreatic disease

研究组 & 干预措施

UCMSC

Experimental

infusion of aUCMSC and Ursodeoxycholic acid therapy

干预措施: UDCA (Drug)

UCMSC

Experimental

infusion of aUCMSC and Ursodeoxycholic acid therapy

干预措施: UCMSC (Drug)

UDCA

Active Comparator

Ursodeoxycholic acid therapy 15mg/kg/d

干预措施: UDCA (Drug)

结局指标

主要结局

adverse effects regarding UCMSC infusion

时间窗: 1 year

次要结局

  • Pathological score of liver inflammation(1 year)
  • alanine aminotransferase(1 year)
  • Changes of biliary lesions in magnetic resonance image(1 year)

研究者

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

Dongliang Li

Professor

Fuzhou General Hospital

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