- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516006
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
Conditions
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.
Sponsor
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Primary Sclerosing Cholangitis
-
Medical University of WarsawNational Science Centre, PolandRecruitingPrimary Sclerosing Cholangitis (PSC)Poland
-
Mayo ClinicActive, not recruiting
-
Cascade Pharmaceuticals, IncCovanceCompletedPrimary Sclerosing Cholangitis (PSC)United States
-
HighTide Biopharma Pty LtdCompletedPrimary Sclerosing Cholangitis (PSC)United States, Canada
-
Intercept PharmaceuticalsCompletedPrimary Sclerosing Cholangitis (PSC)United States, Italy
-
Mirum Pharmaceuticals, Inc.CompletedPrimary Sclerosing Cholangitis (PSC)United States, United Kingdom, Canada
-
Mayo ClinicCompletedPrimary Sclerosing Cholangitis (PSC)United States
-
Boston Scientific CorporationCompletedPrimary Sclerosing Cholangitis (PSC)United States, Canada, Netherlands, Norway
-
Gilead SciencesCompletedPrimary Sclerosing Cholangitis (PSC)United States, Belgium, Canada, Germany, United Kingdom, Italy, Spain, Denmark, Netherlands, Sweden
-
RenJi HospitalRecruitingPrimary Sclerosing Cholangitis | IgG4-related Sclerosing CholangitisChina
Clinical Trials on UCMSC
-
Affiliated Hospital to Academy of Military Medical...Ivy Institute of Stem Cells Co. LtdUnknownHeart Failure | Angina | Chronic Ischemic Heart DiseaseChina
-
Affiliated Hospital to Academy of Military Medical...Ivy Institute of Stem Cells Co. LtdUnknownAcute Respiratory Distress Syndrome | Acute Lung InjuryChina
-
The Second Affiliated Hospital of Fujian Medical...Shanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaUnknown
-
Affiliated Hospital to Academy of Military Medical...Ivy Institute of Stem Cells Co. LtdUnknownUlcerative ColitisChina
-
Affiliated Hospital to Academy of Military Medical...Ivy Institute of Stem Cells Co. LtdUnknownLung Injury | Paraquat PoisoningChina
-
Wuhan Union Hospital, ChinaNot yet recruitingInfections | Acute Myeloid Leukemia | Anemia | Bleeding | Thrombocytopenia | Neutropenia
-
Instituto de Medicina RegenerativaActive, not recruitingCovid-19 | ARDS, HumanMexico
-
Kementerian Riset dan Teknologi / Badan Riset dan...Dr. Moewardi General Hospital, Surakarta, Indonesia; Dr. Sardjito General Hospital... and other collaboratorsRecruiting
-
Universidad de los Andes, ChileCompletedDilated CardiomyopathyChile
-
Marie Hudson, MDAssistance Publique - Hôpitaux de Paris; Medical University of South Carolina; Centre hospitalier de l'Université de Montréal (CHUM) and other collaboratorsRecruitingMesenchymal Stem Cells | Sclerosis, SystemicCanada