Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

• Status: Active, not recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fuzhou General Hospital
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• progressive PSC

• willing to give consent

Exclusion Criteria:

• 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