Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: UCMSC; Drug: UDCA

Study type: Interventional

Funder types: Other

Identifiers

NCT03516006

UCMSC-PSC

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

UCMSC

Experimental group

Description:

infusion of aUCMSC and Ursodeoxycholic acid therapy

Treatment:

Drug: UDCA

Drug: UCMSC

UDCA

Active Comparator group

Description:

Ursodeoxycholic acid therapy 15mg/kg/d

Treatment:

Drug: UDCA