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
About this trial
This is an interventional treatment trial for Primary Sclerosing Cholangitis
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
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
NCT ID
NCT03516006
First Posted
September 20, 2017
Last Updated
April 23, 2018
Sponsor
Fuzhou General Hospital
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
Learn more about this trial
Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
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