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Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

NCT03516006 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-05-04

No results posted yet for this study

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

DRUG

UCMSC

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

DRUG

UDCA

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

Sponsors & Collaborators

  • Fuzhou General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-01-31
Completion
2024-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516006 on ClinicalTrials.gov