Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

NCT03516006 | Unknown Phase 1 DMC

• 1 other identifier: UCMSC-PSC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

• adverse effects regarding UCMSC infusion

  1 year

Secondary Outcomes (3)

• Pathological score of liver inflammation

  1 year

• Changes of biliary lesions in magnetic resonance image

  1 year

• alanine aminotransferase

  1 year

Study Arms (2)

UCMSC

EXPERIMENTAL

infusion of aUCMSC and Ursodeoxycholic acid therapy

Drug: UCMSC; Drug: UDCA

UDCA

ACTIVE COMPARATOR

Ursodeoxycholic acid therapy 15mg/kg/d

Drug: UDCA

Interventions

UCMSC DRUG

infusion of aUCMSC at day 0, 7, 14, and 21

UCMSC

UDCA DRUG

oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d

UCMSC; UDCA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• progressive PSC
• willing to give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuzhou General Hospital: lead

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: May 4, 2018
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2024
• Last Updated: May 4, 2018

Record last verified: 2018-04