Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT05985863

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

Led by Beijing 302 Hospital · Updated on 2024-05-07

150

Participants Needed

1

Research Sites

274 weeks

Total Duration

On this page

Sponsors

B

Beijing 302 Hospital

Lead Sponsor

S

Shulan (Hang Zhou) Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Diagnosis of acute-on-chronic liver failure (ACLF) by APASL criteria, including recent liver injury with jaundice (total bilirubin 25 mg/dL) and coagulopathy (INR 1.5 or prothrombin activity <40%), with ascites or encephalopathy within 4 weeks
  • Willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Acute kidney injury, upper gastrointestinal bleeding, hepatic encephalopathy grade II or higher, or uncontrolled infection at baseline
  • Platelet count less than 50 x 10^9/L or Child-Pugh score greater than 9 before liver failure
  • Liver cancer or other malignant tumors
  • Previous liver transplant or planned liver transplant within 3 months
  • Severe disease of major non-liver organs
  • History of venous thrombosis or pulmonary embolism judged unsuitable by investigator
  • Pregnant, breastfeeding, or planning pregnancy soon
  • Known severe allergies or history of severe allergic reactions
  • Immunosuppressant or immune enhancer treatment within 1 month
  • Drug abuse in past 5 years
  • Alcohol withdrawal symptoms
  • Severe mental disorders in past 24 months, including uncontrolled depression or psychosis
  • Participation in other clinical trials within 3 months or prior stem cell therapy
  • Other conditions deemed unsuitable by investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

the Fifth Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100039

Actively Recruiting

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Research Team

T

Tao Yang, MD

CONTACT

Y

Yanhu Wang, MM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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