Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing 302 Hospital

About this trial

This study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the treatment of acute-on-chronic liver failure (ACLF). UC-MSC therapy may improve the clinical outcomes of patients with ACLF. The trial would provide scientific evidence for UC-MSC transplantation as a potential treatment for ACLF.

Eligibility criteria

Qualifiers

18 years old ≤ age ≤ 70 years old, gender is not limited.

Meet the APASL definition of ACLF: acute liver injury in patients with previously diagnosed or undiagnosed chronic liver disease or cirrhosis, manifested as jaundice (total bilirubin levels of 5 mg/dl or more) and coagulopathy (INR of 1.5 or more, or prothrombin activity of less than 40%) complicated within 4 weeks by clinical ascites, encephalopathy, or both.

Willing to sign the informed consent form.

Disqualifiers

Patients with acute kidney injury, upper gastrointestinal hemorrhage, hepatic encephalopathy above grade II (inclusive) or uncontrolled infection at baseline;

Before the onset of liver failure, the previous indicators of the patient included PLT<50×10^9/L or Child-Pugh score>9;

Combined with liver cancer or other malignant tumors;

Patients with previous liver transplantation or planned liver transplantation within 3 months;

Trial design

Treatments tested in this trial

  • standard medical treatment
  • Placebo
  • hUC-MSC
  • hUC-MSC_Prolonged

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Beijing 302 Hospital

Lead sponsor

Shulan (Hang Zhou) Hospital

Collaborator

BeijingYouan Hospital

Collaborator

Shenzhen Third People's Hospital

Collaborator

Shen Zhen Wingor Biotechnology CO. LTD

Collaborator