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NCT03516006 Clinical Trial

Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03516006
Other study ID # UCMSC-PSC
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2017
Est. completion date January 2024

Study information
Verified date April 2018
Source Fuzhou General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date January 2024
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• UCMSC
infusion of aUCMSC at day 0, 7, 14, and 21
• UDCA
oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fuzhou General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary adverse effects regarding UCMSC infusion 1 year
Secondary Pathological score of liver inflammation 1 year
Secondary Changes of biliary lesions in magnetic resonance image softening in stiffness of bile duct 1 year
Secondary alanine aminotransferase 1 year
See also
  Status Clinical Trial Phase
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Withdrawn NCT03216876 - A Study Of Ursolic Acid For Primary Sclerosing Cholangitis Phase 1
Recruiting NCT02605213 - Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients Phase 4
Recruiting NCT01688024 - Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis Phase 2
Completed NCT03041662 - Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
Completed NCT05866809 - Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis Phase 2
Recruiting NCT05618145 - National Database on Primary Sclerosing Cholangitis (PSC)
Active, not recruiting NCT02446665 - Disease Status in Primary Sclerosing Cholangitis by Elastography N/A
Completed NCT02247934 - Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC) N/A
Terminated NCT01142323 - Pilot Study of Fenofibrate for PSC Phase 1/Phase 2
Completed NCT01088607 - Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis Phase 1
Terminated NCT04060147 - Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis Phase 1
Recruiting NCT04133792 - Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) Phase 3
Active, not recruiting NCT04595825 - CM-101 in PSC Patients -The SPRING Study Phase 2
Recruiting NCT03183570 - Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT Early Phase 1
Completed NCT02943460 - Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis Phase 2
Completed NCT00951327 - Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP) N/A
Completed NCT04024813 - A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC Phase 2
Recruiting NCT05912387 - Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study Early Phase 1
Completed NCT02884557 - NKT Role in the Regulation of the Inflammatory Bowel Disease N/A