Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03516006
• Date of registration: 20/09/2017
• Prospective Registration: No
• Primary sponsor: Fuzhou General Hospital
• Public title: Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
• Scientific title: Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
• Date of first enrolment: January 2017
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03516006
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sclerosing Cholangitis

Intervention(s)

Drug: UDCA

Drug: UCMSC

Primary Outcome(s)

adverse effects regarding UCMSC infusion [Time Frame: 1 year]

Secondary Outcome(s)

Changes of biliary lesions in magnetic resonance image [Time Frame: 1 year]

Pathological score of liver inflammation [Time Frame: 1 year]

alanine aminotransferase [Time Frame: 1 year]

Secondary ID(s)

UCMSC-PSC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors