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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


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
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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
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