Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

Phase 1

• Conditions: Primary Sclerosing Cholangitis
• Interventions: Drug: UCMSC; Drug: UDCA

• Registration Number: NCT03516006
• Lead Sponsor: Fuzhou General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-09-20
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-23
• Last Update Submitted: 2018-04-23
• Study First Posted: 2018-05-04
• Last Update Posted: 2018-05-04
• Primary Completion: 2019-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UCMSC	UCMSC	infusion of aUCMSC and Ursodeoxycholic acid therapy
UDCA	UDCA	Ursodeoxycholic acid therapy 15mg/kg/d
UCMSC	UDCA	infusion of aUCMSC and Ursodeoxycholic acid therapy

Primary Outcome Measures

Name	Time	Method
adverse effects regarding UCMSC infusion	1 year

Secondary Outcome Measures

Name	Time	Method
Pathological score of liver inflammation	1 year
alanine aminotransferase	1 year
Changes of biliary lesions in magnetic resonance image	1 year	softening in stiffness of bile duct