drugset / Trial / NCT03516006

Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

NCT03516006

Phase 1/2 Unknown 20 enrolled Fuzhou General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-01
Primary completion
2019-01
Completion
2024-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ursodeoxycholic Acid Small molecule 15 mg/kg Oral
Subject human umbilical cord mesenchymal stem cells Cell therapy Other