NCT03945487

Brief Summary

Decompensated liver cirrhosis is a life-threatening chronic liver disease with high mortality. Liver transplantation is the only option that can improve the survival of these patients; however, this procedure is associated with several limitations, such as the severe shortage of donor livers, long waiting lists, multiple complications, and high cost. Our and other previous studies have demonstrated that marrow bone-derived mesenchymal stem cells (BM-MSC) or unbilical cord derived MSC (UC-MSC) infusion is clinically safe and could improve liver function in patients with decompensated liver cirrhosis. However, the long-term outcomes of MSC infusion have not been reported until now. This prospective and randomized controlled study examined the longer-term safety and efficacy of UC-MSC in patients with decompensated liver cirrhosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

2.6 years

First QC Date

May 9, 2019

Last Update Submit

May 9, 2019

Conditions

Decompensated Liver Cirrhosis

Keywords

liver cirrhosismesenchymal stem cellssafetyliver function

Outcome Measures

Primary Outcomes (2)

  • Liver function

    including the levels of albumin \[ALB\], prothrombin activity \[PTA\], total bilirubin \[TBIL, and cholinesterase \[CHE\].

    96 weeks

  • The incidence of serious complications

    including infection, gastrointestinal bleeding, encephalopathy, and hepatorenal syndrome.

    96 weeks

Secondary Outcomes (3)

  • The incidence of adverse events

    96 weeks

  • Disease-free survival time

    96 weeks

  • Incidence of hepatocellular carcinoma (HCC) events

    96 weeks

Study Arms (2)

Comprehensive treatment plus UC-MSC treatment

EXPERIMENTAL
Biological: umbilical cord-derived mesenchymal stem cell

Comprehensive treatment

OTHER
Other: Comprehensive treatment

Interventions

umbilical cord-derived mesenchymal stem cellBIOLOGICAL

Taken a dose of 1.0\*10E6 UC-MSC/kg body weight intravenously three times at 3-week intervals, in addition to comprehensive treatment.

Comprehensive treatment plus UC-MSC treatment
Comprehensive treatmentOTHER

1. All patients received anti-HBV treatment with NAs (entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF)). 2. Strategies based on targeting abnormalities in gut-liver axis by antibiotic administration (i.e. rifaximin), improving the disturbed systemic circulatory function (i.e. longterm albumin administration), decreasing the inflammatory state (i.e. statins), and reducing portal hypertension (i.e. beta-blockers).

Comprehensive treatment

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-69 years;
  • Decompensated liver cirrhosis (manifestations including gastrointestinal bleeding, hepatic encephalopathy, and ascites, based on previously stable cirrhosis);
  • Positive testing for serum hepatitis B surface antigen (HBsAg) for more than 6 months (chronic hepatitis B patients);
  • Written consent.

You may not qualify if:

  • Hepatocellular carcinoma or other malignancies;
  • Liver cirrhosis caused by other reasons, such as autoimmune diseases, alcocal, drugs and so on;
  • Pregnant women;
  • The presence of other vital organ severe dysfunction;
  • Participate in other studies;
  • Lack of a supportive family;
  • Refusal to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing 302 Hospital

Beijing, 100039, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fu-Sheng Wang

    Beijing 302 Hospital

    STUDY CHAIR

Central Study Contacts

Ming Shi

CONTACT

86-10-63879735shiming302@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Treatment and Research Center for Infectious Diseases

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 10, 2019

Study Start

May 20, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2023

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)