NCT03516006

Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	UCMSC	infusion of aUCMSC at day 0, 7, 14, and 21
DRUG	UDCA	oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-01-01
• Completion: 2024-01-01
• First posted: 2018-05-04
• Last updated: 2018-05-04