Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03516006

Enrollment

Registered

2018-05-04

Start date

2017-01-31

Completion date

2024-01-31

Last updated

2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sclerosing Cholangitis

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.

Interventions

DRUGUCMSC

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

DRUGUDCA

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
adverse effects regarding UCMSC infusion	1 year

Secondary

Measure	Time frame	Description
Pathological score of liver inflammation	1 year	—
Changes of biliary lesions in magnetic resonance image	1 year	softening in stiffness of bile duct
alanine aminotransferase	1 year	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026