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Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

Primary Purpose

Primary Sclerosing Cholangitis

Status
Active
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
UCMSC
UDCA
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    UCMSC

    UDCA

    Arm Description

    infusion of aUCMSC and Ursodeoxycholic acid therapy

    Ursodeoxycholic acid therapy 15mg/kg/d

    Outcomes

    Primary Outcome Measures

    adverse effects regarding UCMSC infusion

    Secondary Outcome Measures

    Pathological score of liver inflammation
    Changes of biliary lesions in magnetic resonance image
    softening in stiffness of bile duct
    alanine aminotransferase

    Full Information

    First Posted
    September 20, 2017
    Last Updated
    April 23, 2018
    Sponsor
    Fuzhou General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03516006
    Brief Title
    Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
    Official Title
    Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fuzhou General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Sclerosing Cholangitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    UCMSC
    Arm Type
    Experimental
    Arm Description
    infusion of aUCMSC and Ursodeoxycholic acid therapy
    Arm Title
    UDCA
    Arm Type
    Active Comparator
    Arm Description
    Ursodeoxycholic acid therapy 15mg/kg/d
    Intervention Type
    Drug
    Intervention Name(s)
    UCMSC
    Intervention Description
    infusion of aUCMSC at day 0, 7, 14, and 21
    Intervention Type
    Drug
    Intervention Name(s)
    UDCA
    Intervention Description
    oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d
    Primary Outcome Measure Information:
    Title
    adverse effects regarding UCMSC infusion
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Pathological score of liver inflammation
    Time Frame
    1 year
    Title
    Changes of biliary lesions in magnetic resonance image
    Description
    softening in stiffness of bile duct
    Time Frame
    1 year
    Title
    alanine aminotransferase
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

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