NCT03863002

Brief Summary

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

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
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2019

Typical duration for phase_1

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

February 18, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 20, 2019

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

February 18, 2019

Last Update Submit

March 18, 2019

Conditions

Liver Failure, Acute on Chronic

Keywords

mesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

  • survival rate

    Number of participants alive

    72 weeks after treatment

Secondary Outcomes (13)

  • Adverse reactions

    Week 1, 2, 4, 8, 12, 24, 36, 48

  • White blood cell

    Week 1, 2, 4, 8, 12, 24, 36, 48

  • Platelet

    Week 1, 2, 4, 8, 12, 24, 36, 48

  • Hemoglobin

    Week 1, 2, 4, 8, 12, 24, 36, 48

  • Creatinine

    Week 1, 2, 4, 8, 12, 24, 36, 48

  • +8 more secondary outcomes

Study Arms (2)

Standard Medical Treatment

NO INTERVENTION

Standard Medical Treatment (SMT): All patients received SMT, including nutritional supplementation; administration of human serum albumin (serum albumin \<30 g/L), fresh frozen plasma (200-400 mL/day until the INR was \<1.5), S-adenosylmethionine (1.0 g/day); or anti-virus treatment for hepatic viruses-related cases, and appropriate treatment for complications such as infections (including of the respiratory tract, urinary tract, biliary tract, and digestive tract and spontaneous peritonitis), encephalopathy, gastrointestinal bleeding, and hepatorenal syndrome \[HRS\]).

Mesenchymal Stem Cell

EXPERIMENTAL

Mesenchymal Stem Cell (MSC): The MSC group received infusions of 1.0 to 10x10\^5cells/kg MSCs through the peripheral vein once a week for 4 weeks, in addition to SMT.

Biological: Mesenchymal Stem Cell

Interventions

Mesenchymal Stem CellBIOLOGICAL

Mesenchymal stem cell transplantation via peripheral vein: 1.0-10x10\^5 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2, 3 weeks

Mesenchymal Stem Cell

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Informed consent
  • Meeting the definition of ACLF: patients with previously diagnosed or undiagnosed chronic liver disease acute decompensated within 4 weeks; significant GI symptom as such fatigue, jaundice; serum total bilirubin \[TBil\] ≥10 X the upper limit of normal; coagulopathy (international normalized ratio \[INR\] ≥1.5 or prothrombin activity \[PTA\] \<40%); complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination.
  • Model for End-Stage Liver Disease (MELD) scores ranging 17-30, (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643);
  • Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
  • Body weight ≥50kg

You may not qualify if:

  • Serious complications in the previous 2 months (e.g., gastrointestinal bleeding: hemoglobin below 90g/L, serious infection such as sepsis, ascites ultrafiltration, and/or dialysis);
  • Malignant jaundice induced by obstructive jaundice or hemolytic jaundice;
  • Hepatocellular carcinoma (HCC) diagnosed by radiologic imaging and/or alpha fetoprotein (AFP);
  • Tumor diagnosed by ultrasound, CT, MR examination;
  • Moderate or severe chronic heart failure (NYHA III-IV), renal replacement therapy, severe chronic pulmonary disease (GOLD III-IV)
  • Extrahepatic cholestasis
  • Hepatic, portal and splenic vein thrombosis diagnosed by doppler ultrasound
  • Artificial liver support
  • Previous liver transplantation
  • Drug abuse in the past 5 years;
  • Mental disorders and/or has a family history of mental disorder.
  • HIV infection
  • Pregnant or breast-feeding females
  • Highly allergic
  • Patients can not cooperate or mobility
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Weikai Bioeng., Ltd.

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Central Study Contacts

Xiuli Cong, MD, PhD

CONTACT

+86 18512507567cong_xiuli@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
both participants and the study team are unblinded to the treatment allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

March 5, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

March 20, 2019

Record last verified: 2018-04

Locations

CN(1)