Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UCMSC

infusion of aUCMSC and Ursodeoxycholic acid therapy

Group Type EXPERIMENTAL

UCMSC

Intervention Type DRUG

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

UDCA

Intervention Type DRUG

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

UDCA

Ursodeoxycholic acid therapy 15mg/kg/d

Group Type ACTIVE_COMPARATOR

UDCA

Intervention Type DRUG

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

Interventions

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UCMSC

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

Intervention Type DRUG

UDCA

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No