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Trial record 9 of 92 for:    Primary Sclerosing Cholangitis

Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

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ClinicalTrials.gov Identifier: NCT03516006
Recruitment Status : Active, not recruiting
First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dongliang Li, Fuzhou General Hospital

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.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: UCMSC Drug: UDCA Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
Experimental: UCMSC
infusion of aUCMSC and Ursodeoxycholic acid therapy
Drug: UCMSC
infusion of aUCMSC at day 0, 7, 14, and 21

Drug: UDCA
oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d

Active Comparator: UDCA
Ursodeoxycholic acid therapy 15mg/kg/d
Drug: UDCA
oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d




Primary Outcome Measures :
  1. adverse effects regarding UCMSC infusion [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Pathological score of liver inflammation [ Time Frame: 1 year ]
  2. Changes of biliary lesions in magnetic resonance image [ Time Frame: 1 year ]
    softening in stiffness of bile duct

  3. alanine aminotransferase [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Dongliang Li, Professor, Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT03516006     History of Changes
Other Study ID Numbers: UCMSC-PSC
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents