Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

April 23, 2018 updated by: Dongliang Li, Fuzhou General Hospital

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

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UCMSC
infusion of aUCMSC and Ursodeoxycholic acid therapy
infusion of aUCMSC at day 0, 7, 14, and 21
oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d
Active Comparator: UDCA
Ursodeoxycholic acid therapy 15mg/kg/d
oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adverse effects regarding UCMSC infusion
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • UCMSC-PSC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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