Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
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
- 否
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
infusion of aUCMSC and Ursodeoxycholic acid therapy
干预措施: UDCA (Drug)
UCMSC
infusion of aUCMSC and Ursodeoxycholic acid therapy
干预措施: UCMSC (Drug)
UDCA
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
Dongliang Li
Professor
Fuzhou General Hospital
